Job
Title
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Location
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Link
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Operations
Manager
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Colombia
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Stream
Manager
|
United States
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Statistician
|
United States
|
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Admin
Assistant
|
Switzerland
|
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Procurement
Assistant
|
United States
|
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Management
Specialist
|
Mexico
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Research
Director
|
United States
|
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Payable
Executive
|
United Kingdom
|
|
Quality
Control Lab Manager
|
United states
|
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ADMIN
ASSISTANT
ROLES:
• Provide
administrative support to agreed Leaders, by using exceptional business
knowledge, stakeholder management, administrative abilities and personal
judgement to execute primary responsibilities.
• Arranging travel produces detailed itineraries and trip files and prepares expense reports for agreed Leaders within the team (SLT-1 & 2 Leaders and agreed SLT-3 Leaders only).
• Prepare meeting pre-reads for Leaders key meetings.
• Word processing: letters, memoranda, reports and e-mail, responding on behalf of SVP and VPs as appropriate. Preparation of Board Papers. Preparation of presentation material using PowerPoint and spreadsheets using Excel
• Diary management: arranging a variety of appointments and meetings, ensuring team have the time to complete projects whilst dealing with changing/conflicting priorities and maintaining routine meetings and day-to -day contact with customers and team members.
• Track and report on department vacation / time off
• Responds to complex inquiries from internal and external personnel using proper judgment and initiative to ensure critical issues are handled appropriately.
• Administering various meetings e.g. departmental meetings: Arranging dates, controlling/arranging agenda items, distributing minutes.
• Reviewing, prioritizing and informing managers of incoming urgent correspondence or communications requiring action or resolution in manager’s absence.
• Organizes team meetings and facilitates sharing of information to help ensure continuous improvement of service.
• Must be able to work in a team environment. Initiative and ensuring urgent matters are addressed. Plan and manages long-term work as well as daily tasks.
• Filing: Maintaining a filing system for a range of documents both hard copy and electronic. Aligning files to records retention policy.
• Maintaining and updating departmental shared area and electronic databases as required.
• Orders/maintains supplies for group.
• Keeps track of monthly Procurement Card for bill processing & manages expenses reports for team.
The ideal candidates will have a strong administrative background, supporting senior leaders in a multinational, matrixed organisation. An understanding of the Pharmaceutical or Healthcare industry, particularly knowledge of R&D or Regulatory functions, would be highly beneficial. We are constantly evolving our ways of working therefore the successful candidates will need to be able to adapt to change quickly and demonstrate flexibility and agility.
• Arranging travel produces detailed itineraries and trip files and prepares expense reports for agreed Leaders within the team (SLT-1 & 2 Leaders and agreed SLT-3 Leaders only).
• Prepare meeting pre-reads for Leaders key meetings.
• Word processing: letters, memoranda, reports and e-mail, responding on behalf of SVP and VPs as appropriate. Preparation of Board Papers. Preparation of presentation material using PowerPoint and spreadsheets using Excel
• Diary management: arranging a variety of appointments and meetings, ensuring team have the time to complete projects whilst dealing with changing/conflicting priorities and maintaining routine meetings and day-to -day contact with customers and team members.
• Track and report on department vacation / time off
• Responds to complex inquiries from internal and external personnel using proper judgment and initiative to ensure critical issues are handled appropriately.
• Administering various meetings e.g. departmental meetings: Arranging dates, controlling/arranging agenda items, distributing minutes.
• Reviewing, prioritizing and informing managers of incoming urgent correspondence or communications requiring action or resolution in manager’s absence.
• Organizes team meetings and facilitates sharing of information to help ensure continuous improvement of service.
• Must be able to work in a team environment. Initiative and ensuring urgent matters are addressed. Plan and manages long-term work as well as daily tasks.
• Filing: Maintaining a filing system for a range of documents both hard copy and electronic. Aligning files to records retention policy.
• Maintaining and updating departmental shared area and electronic databases as required.
• Orders/maintains supplies for group.
• Keeps track of monthly Procurement Card for bill processing & manages expenses reports for team.
The ideal candidates will have a strong administrative background, supporting senior leaders in a multinational, matrixed organisation. An understanding of the Pharmaceutical or Healthcare industry, particularly knowledge of R&D or Regulatory functions, would be highly beneficial. We are constantly evolving our ways of working therefore the successful candidates will need to be able to adapt to change quickly and demonstrate flexibility and agility.
QUALIFICATION
Understanding of the
Pharmaceutical or Healthcare industry, particularly knowledge of R&D or
Regulatory functions, would be highly beneficial.
OPERATIONS
MANAGER
ROLES:
Ensure LOC Quality
processes and systems are in place for all activities carried out across the
Local Business ensuring as well that they are in compliance with GSK standards
and policies, Guide for Commercial Companies, GMP, GDP and regulatory requirements.
These processes and systems would related (but not limited) to:
• Product supply. Develop, specify and approve processes and systems that have an impact on the quality of products in line with QMS and local regulatory requirements:
o Accountable for review and approval of TTS (Technical Terms of Supply) and liaison with manufacturing sites to ensure compliance to local registered technical details (in connection with local regulatory team).
o Liaison with External Supply (ES) Quality for products that are manufactured by contractors to ensure compliance to local registered technical details (in connection with local regulatory team). Accountable for review and approval of the Quality Agreement per product per ES.
o Ensure any Third Party Supplier (3PL) providing GxP services to the LOC is audited by central audit functions, and a Quality Agreement is in place
o Perform routine checks on validity of local GDP/ GMP Licenses held by all 3PLs and third party distributors.
• Batch management & Release to Market. To lead batch assessment and release activities to ensure releases are carried out efficiently, in a timely manner, and meeting relevant regulatory standards (for those cases in which the release process is not carried by a third party)
o Perform all Duty of Care activities and to release the product to the local market
o Where applicable, this position could also be the Qualified Person or Qualified person Deputy to release finished products to the markets.
o Investigate and resolve Quality-related issues arising from the deliveries with Area Quality Lead, Logistic Services Provider (LSPs) and supplying sites.
o Manage temperature excursions from deliveries from supplying sites to MMW and MMW to local warehouses where applicable.
o Where applicable, ensure timely local Quality release of imported finished goods deliveries
o Perform all quality activities into CERPS and GMM as appropriate
• Positive release/quarantine. LOC QA Operational Manager has oversight on positive release process for products in their LOC.
• Local Repacking. Manage all matters pertaining to GxP, Regulatory and & QMS compliance for repacking procedures to ensure timely QA approval before initiate any re-packing activity as well as to ensure timely QA batch release of repacked orders before distribution and/or re-export. Ensure documentation of batch records including repack protocol and retention of samples, where applicable.
• Recall & Incident management. Part of local LIC Team as appropriate.
• Collaborate with self-inspection, and other forms of evaluation (L2 monitoring audits, third party monitoring audits) to ensure that local operations are in full compliance with GSK standards and policies, , GSK QMS, GMP, GDP and regulatory requirements for all of marketed products (medicinal products, medical devices, cosmetics, foods, others).
• Corrective and Preventive Actions (CAPA), RCA, Deviations- Conduct root cause analysis to investigate GxP deviations and develop CAPA’s. Local Demonstrate that LOC effectively identifies where CAPA plans required and that they are effectively implemented, monitored and closed out
• Change Control - Manage all planned major GxP changes (including new pack introduction, product discontinuation, major pack changes, re-packing activities). Change control process links to risk management process and risk assessments completed. Processes in place to routinely review progress of changes and close out when completed.
• Auditing – Give support in L1/L2 audit conduction and receipt of L3/L4 audits.
• Provide support to the quality alerts and regulatory intelligence processes managed by the compliance area
• Support the maintenance of the QMS through the appropriate impact assessment and QMS Management review processes managed by the compliance area
• Product supply. Develop, specify and approve processes and systems that have an impact on the quality of products in line with QMS and local regulatory requirements:
o Accountable for review and approval of TTS (Technical Terms of Supply) and liaison with manufacturing sites to ensure compliance to local registered technical details (in connection with local regulatory team).
o Liaison with External Supply (ES) Quality for products that are manufactured by contractors to ensure compliance to local registered technical details (in connection with local regulatory team). Accountable for review and approval of the Quality Agreement per product per ES.
o Ensure any Third Party Supplier (3PL) providing GxP services to the LOC is audited by central audit functions, and a Quality Agreement is in place
o Perform routine checks on validity of local GDP/ GMP Licenses held by all 3PLs and third party distributors.
• Batch management & Release to Market. To lead batch assessment and release activities to ensure releases are carried out efficiently, in a timely manner, and meeting relevant regulatory standards (for those cases in which the release process is not carried by a third party)
o Perform all Duty of Care activities and to release the product to the local market
o Where applicable, this position could also be the Qualified Person or Qualified person Deputy to release finished products to the markets.
o Investigate and resolve Quality-related issues arising from the deliveries with Area Quality Lead, Logistic Services Provider (LSPs) and supplying sites.
o Manage temperature excursions from deliveries from supplying sites to MMW and MMW to local warehouses where applicable.
o Where applicable, ensure timely local Quality release of imported finished goods deliveries
o Perform all quality activities into CERPS and GMM as appropriate
• Positive release/quarantine. LOC QA Operational Manager has oversight on positive release process for products in their LOC.
• Local Repacking. Manage all matters pertaining to GxP, Regulatory and & QMS compliance for repacking procedures to ensure timely QA approval before initiate any re-packing activity as well as to ensure timely QA batch release of repacked orders before distribution and/or re-export. Ensure documentation of batch records including repack protocol and retention of samples, where applicable.
• Recall & Incident management. Part of local LIC Team as appropriate.
• Collaborate with self-inspection, and other forms of evaluation (L2 monitoring audits, third party monitoring audits) to ensure that local operations are in full compliance with GSK standards and policies, , GSK QMS, GMP, GDP and regulatory requirements for all of marketed products (medicinal products, medical devices, cosmetics, foods, others).
• Corrective and Preventive Actions (CAPA), RCA, Deviations- Conduct root cause analysis to investigate GxP deviations and develop CAPA’s. Local Demonstrate that LOC effectively identifies where CAPA plans required and that they are effectively implemented, monitored and closed out
• Change Control - Manage all planned major GxP changes (including new pack introduction, product discontinuation, major pack changes, re-packing activities). Change control process links to risk management process and risk assessments completed. Processes in place to routinely review progress of changes and close out when completed.
• Auditing – Give support in L1/L2 audit conduction and receipt of L3/L4 audits.
• Provide support to the quality alerts and regulatory intelligence processes managed by the compliance area
• Support the maintenance of the QMS through the appropriate impact assessment and QMS Management review processes managed by the compliance area
QUALIFICATION
Graduate
in, Chemistry, Pharmacy, Engineering, Microbiology or another related science.
Quality experience within the industry, and application of Quality Systems & Quality Operations
• Minimum of 5 years experience within the Pharmaceutical / Consumer Healthcare Industries, preferably in the capacity of a quality specialist or a manager
• Knowledge of regulatory requirements pertaining to GMP/GDP.
• understanding of and experience in quality assurance systems particularly in the areas of batch release, product incidents, artwork control and performing audits
• Knowledge on effective quality documentation systems
• Professional written and verbal communication skills. Able to deliver positive and proactive communications and foster excellent working relationships with stakeholders at any level of the organization
• Ability to influence and motivate stakeholders at any level of the LOC organization
• Analytical mind, good attention to detail and problem solving skills within a structured process
• Good team player – works well in cross-functional teams
• Good time management skills, with ability to multi-task and work under pressure
• Strong interpersonal and negotiation skills
• Concise and persuasive in the description of the different QA situations. Able to stick to the standard and not be pressurized.
• Works with a spirit of continuous improvement and innovation, creatively open to new ideas and methods
• Flexible Flethinking – able to challenge and see views from different perspectives
• Ability to self-motivate and be resilient and focused under pressure
• Able to work effectively in English
• Strong general computer literacy with Intermediate skills in Microsoft Word, Excel, Power Point and Outlook
Quality experience within the industry, and application of Quality Systems & Quality Operations
• Minimum of 5 years experience within the Pharmaceutical / Consumer Healthcare Industries, preferably in the capacity of a quality specialist or a manager
• Knowledge of regulatory requirements pertaining to GMP/GDP.
• understanding of and experience in quality assurance systems particularly in the areas of batch release, product incidents, artwork control and performing audits
• Knowledge on effective quality documentation systems
• Professional written and verbal communication skills. Able to deliver positive and proactive communications and foster excellent working relationships with stakeholders at any level of the organization
• Ability to influence and motivate stakeholders at any level of the LOC organization
• Analytical mind, good attention to detail and problem solving skills within a structured process
• Good team player – works well in cross-functional teams
• Good time management skills, with ability to multi-task and work under pressure
• Strong interpersonal and negotiation skills
• Concise and persuasive in the description of the different QA situations. Able to stick to the standard and not be pressurized.
• Works with a spirit of continuous improvement and innovation, creatively open to new ideas and methods
• Flexible Flethinking – able to challenge and see views from different perspectives
• Ability to self-motivate and be resilient and focused under pressure
• Able to work effectively in English
• Strong general computer literacy with Intermediate skills in Microsoft Word, Excel, Power Point and Outlook
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