Manage QA & Compliance requirements with assigned third party contractor sites to ensure quali-ty of OTC products during the marketed phase. Ensure that all aspects of the pharmaceutical products at assigned third party contractor sites comply with the requirements of the Novartis Corporate Quality Manual and meet all relevant cGMP regulatory and legislative requirements.
Evaluate and understand the level of cGMP compliance for products manufactured, packaged, test-ed and released at assigned third party contractor sites through defined key performance and quality performance indicators. Ensure performance of risk evaluation and implementation of quality action plans at assigned sites to address risks identified.
Continuously improve, harmonise and establish QA and Compliance systems, strengthen quality awareness, implement the development of third party strategic plans, support third party contract facilities, contract operations, technical services, product/process improvements, eliminate barriers, and investigate quality issues using applicable process improvement and problem solving techniques to assure successful outcomes of Novartis and external Health Authority inspections in all assigned third party sites.
Work with the business partners to help ensure that, whenever possible, the QA activities within the assigned third party sites operate in a cost effective and efficient manner and maintain an in-novative approach based on productivity improvement and implementation of best practice.
Ensure as much as possible that product weaknesses and risks associated with assigned third par-ty sites are known and communicated to the organization so that they can be proactively ad-dressed prior to Novartis or health authority audit observations.
Major Accountabilties
Management of third party contractor sites:
1. Implement Novartis Quality standards and GMP requirements within assigned third party sites to provide direction and support for all quality matters
2. Ensure that Quality Assurance Agreements are established and remain current with assigned third party sites
3. Be the point of contact for all quality matters with assigned third party sites
4. Ensure that investigations associated with assigned third party sites are properly performed, documented, evaluated, and closed as per procedure
5. Ensure that change ontrols associated with assigned third party sites are properly performed, documented, evaluated, executed and closed as per procedure
6. Monitor complaint records, closure, and trending for assigned third party sites by performing periodic trend analysis in the complaint management system
7. Lead complaint investigations when required based on their criticality and / or identified trends in the database
8. Ensure the Head of QA in Pakistan is informed as appropriate of any assigned deviations, change controls, audit findings, or complaints which may have impact on product sold in their market.
9. Track and ensure timely and appropriate closure of effective corrective / preventive actions at assigned third party sites
10. Assist the audit team in audit preparation and participate in the audit execution of assigned third party sites
11. Take the lead to ensure that any commitments given to address audit observations (both No-vartis and Health Authority) by assigned third party sites are implemented as described in the agreed time frame
12. In the event of a product recall assessment, take the lead to ensure that a timely evaluation is performed with cross functional team as described per procedure
13. Work with the global QA organization as a liaison between Novartis and assigned third party sites for any corporate or global initiatives regarding quality and compliance
14. Participate in regular business review meetings and ensure quality topics, KPI’s, and concerns are raised and discussed with Novartis and third party site management
15. In the event of critical quality concerns, ensure that the formal escalation process is followed per procedure
16. Ensure that periodic contractor risk assessments are performed with a cross functional team per procedure
17. Ensure understanding of production processes for Novartis OTC products at assigned third party sites
18. Ensure self and associates on team (as applicable) are trained, knowledgeable, and capable of performing their assigned tasks
19. Ensure stability data is available and appropriately reviewed for products from assigned third party contractors
20. Ensure APR / PQR is available and reviewed in acceptable time period for all products from assigned third party site and appropriate actions are identified and tracked
21. Provide leadership directives and support on quality issues.
22. Utilize active thinking to generate creative solutions to complex technical problems.
Key Performance Indicators
Quality deliverables described in the performance management program
Established monthly and quarterly Key Performance Indicators
Minimum requirements
Education: (minimum/desirable):
Graduate in Chemistry, Pharmacy, Microbiology or another related science, business degree is a plus
Experience:
5-10 years’ experience in Pharmaceutical Industry, 2 years in managerial position in Quality Assurance
Evaluate and understand the level of cGMP compliance for products manufactured, packaged, test-ed and released at assigned third party contractor sites through defined key performance and quality performance indicators. Ensure performance of risk evaluation and implementation of quality action plans at assigned sites to address risks identified.
Continuously improve, harmonise and establish QA and Compliance systems, strengthen quality awareness, implement the development of third party strategic plans, support third party contract facilities, contract operations, technical services, product/process improvements, eliminate barriers, and investigate quality issues using applicable process improvement and problem solving techniques to assure successful outcomes of Novartis and external Health Authority inspections in all assigned third party sites.
Work with the business partners to help ensure that, whenever possible, the QA activities within the assigned third party sites operate in a cost effective and efficient manner and maintain an in-novative approach based on productivity improvement and implementation of best practice.
Ensure as much as possible that product weaknesses and risks associated with assigned third par-ty sites are known and communicated to the organization so that they can be proactively ad-dressed prior to Novartis or health authority audit observations.
Major Accountabilties
Management of third party contractor sites:
1. Implement Novartis Quality standards and GMP requirements within assigned third party sites to provide direction and support for all quality matters
2. Ensure that Quality Assurance Agreements are established and remain current with assigned third party sites
3. Be the point of contact for all quality matters with assigned third party sites
4. Ensure that investigations associated with assigned third party sites are properly performed, documented, evaluated, and closed as per procedure
5. Ensure that change ontrols associated with assigned third party sites are properly performed, documented, evaluated, executed and closed as per procedure
6. Monitor complaint records, closure, and trending for assigned third party sites by performing periodic trend analysis in the complaint management system
7. Lead complaint investigations when required based on their criticality and / or identified trends in the database
8. Ensure the Head of QA in Pakistan is informed as appropriate of any assigned deviations, change controls, audit findings, or complaints which may have impact on product sold in their market.
9. Track and ensure timely and appropriate closure of effective corrective / preventive actions at assigned third party sites
10. Assist the audit team in audit preparation and participate in the audit execution of assigned third party sites
11. Take the lead to ensure that any commitments given to address audit observations (both No-vartis and Health Authority) by assigned third party sites are implemented as described in the agreed time frame
12. In the event of a product recall assessment, take the lead to ensure that a timely evaluation is performed with cross functional team as described per procedure
13. Work with the global QA organization as a liaison between Novartis and assigned third party sites for any corporate or global initiatives regarding quality and compliance
14. Participate in regular business review meetings and ensure quality topics, KPI’s, and concerns are raised and discussed with Novartis and third party site management
15. In the event of critical quality concerns, ensure that the formal escalation process is followed per procedure
16. Ensure that periodic contractor risk assessments are performed with a cross functional team per procedure
17. Ensure understanding of production processes for Novartis OTC products at assigned third party sites
18. Ensure self and associates on team (as applicable) are trained, knowledgeable, and capable of performing their assigned tasks
19. Ensure stability data is available and appropriately reviewed for products from assigned third party contractors
20. Ensure APR / PQR is available and reviewed in acceptable time period for all products from assigned third party site and appropriate actions are identified and tracked
21. Provide leadership directives and support on quality issues.
22. Utilize active thinking to generate creative solutions to complex technical problems.
Key Performance Indicators
Quality deliverables described in the performance management program
Established monthly and quarterly Key Performance Indicators
Minimum requirements
Education: (minimum/desirable):
Graduate in Chemistry, Pharmacy, Microbiology or another related science, business degree is a plus
Experience:
5-10 years’ experience in Pharmaceutical Industry, 2 years in managerial position in Quality Assurance
