Director Quality Assurance
Abbott
Date: 1 week ago
City: Ahmedabad, Gujarat
Contract type: Full time
Job Description
Core Job Responsibilities:
1. To make strategy and planning for Quality Assurance and Quality Control for smooth and effective functioning for ODF, LVP & Hormone block.
2. To strategize and plan for continual improvement of GMP aspects in the facility, systems, and procedures.
3. Budgeting for Capital expenses and Operating expenses. Plan and manage departmental activities in accordance with agreed budgets and time scale. To manage department performance against agreed targets and budgets within policies and standards.
4. Setting Goals for QA and QC, monitoring and guiding them to complete the KRA. Leading and monitor performance (in relevant area) according to agreed standards and take necessary action to communicate/ advise/ assist according to performance level.
5. Work across all disciplines (e.g., Manufacturing, Warehouse, Engineering, etc.) to ensure that the Company maintains a state of readiness for inspection by regulatory agencies/ internal/ external.
6. To ensure timely response against observation of Corporate Internal audits, Customer audits & Regulatory audits, and ensure implementation of corrective & preventive action on observations.
7. To ensure implementation and execution of Abbott Policies and Procedures at site.
8. To ensure continuous improvement at site with respect to Quality systems and processes.
9. To ensure self-inspection/internal audit and external audit as per schedule/ Plan and regularly appraise the effectiveness/ applicability of the Pharmaceutical Quality System.
10. To ensure timely submission of Regulatory Documents and filing and their compliance.
11. To ensure Cyber Security aspects are implemented at site.
12. To develop, ensure, implement, and maintain a GXP compliant document control system.
13. To ensure that Batch Release is done as per in-house policies and procedures as well as the other other applicable regulations and guidelines.
14. To establish & ensure approval / rejection of starting materials, packaging materials, intermediate, bulk & finished products as per validated methods / Pharmacopeia methods / In-house Method for the site.
15. To ensure Product recall is done as site procedure and further coordination with Regional Quality for recall authorization.
16. To ensure that Review Meet is done with the involvement of senior management, to identify the opportunities for continual improvement of products, process, and system.
17. To ensure Quality Risks Management i.e., risks to the quality of the product based on scientific knowledge, experience with the process are mitigated and communicated to senior management as well as linked with the protection of the patient.
18. To approve documentation, as applicable, at site.
19. To approve/reject/extension of Exception/ Deviations and Change Controls activities.
20. To ensure training and effective implementation of current Good Manufacturing Practices.
21. To ensure Good Documentation Practices and Good Laboratory Practices at the site.
22. To ensure that documents are updated and amended as per new pharmacopoeias and regulatory guidelines.
Core Job Responsibilities:
1. To make strategy and planning for Quality Assurance and Quality Control for smooth and effective functioning for ODF, LVP & Hormone block.
2. To strategize and plan for continual improvement of GMP aspects in the facility, systems, and procedures.
3. Budgeting for Capital expenses and Operating expenses. Plan and manage departmental activities in accordance with agreed budgets and time scale. To manage department performance against agreed targets and budgets within policies and standards.
4. Setting Goals for QA and QC, monitoring and guiding them to complete the KRA. Leading and monitor performance (in relevant area) according to agreed standards and take necessary action to communicate/ advise/ assist according to performance level.
5. Work across all disciplines (e.g., Manufacturing, Warehouse, Engineering, etc.) to ensure that the Company maintains a state of readiness for inspection by regulatory agencies/ internal/ external.
6. To ensure timely response against observation of Corporate Internal audits, Customer audits & Regulatory audits, and ensure implementation of corrective & preventive action on observations.
7. To ensure implementation and execution of Abbott Policies and Procedures at site.
8. To ensure continuous improvement at site with respect to Quality systems and processes.
9. To ensure self-inspection/internal audit and external audit as per schedule/ Plan and regularly appraise the effectiveness/ applicability of the Pharmaceutical Quality System.
10. To ensure timely submission of Regulatory Documents and filing and their compliance.
11. To ensure Cyber Security aspects are implemented at site.
12. To develop, ensure, implement, and maintain a GXP compliant document control system.
13. To ensure that Batch Release is done as per in-house policies and procedures as well as the other other applicable regulations and guidelines.
14. To establish & ensure approval / rejection of starting materials, packaging materials, intermediate, bulk & finished products as per validated methods / Pharmacopeia methods / In-house Method for the site.
15. To ensure Product recall is done as site procedure and further coordination with Regional Quality for recall authorization.
16. To ensure that Review Meet is done with the involvement of senior management, to identify the opportunities for continual improvement of products, process, and system.
17. To ensure Quality Risks Management i.e., risks to the quality of the product based on scientific knowledge, experience with the process are mitigated and communicated to senior management as well as linked with the protection of the patient.
18. To approve documentation, as applicable, at site.
19. To approve/reject/extension of Exception/ Deviations and Change Controls activities.
20. To ensure training and effective implementation of current Good Manufacturing Practices.
21. To ensure Good Documentation Practices and Good Laboratory Practices at the site.
22. To ensure that documents are updated and amended as per new pharmacopoeias and regulatory guidelines.
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