Chief Quality Officer

5 days ago

Baddi, Himachal Pradesh, India beBeeQuality Full time ₹ 1,00,00,000 - ₹ 2,00,00,000
Director of Quality Assurance Role

This senior leadership position oversees the development and implementation of quality assurance and control systems to ensure efficient operations.

Key Responsibilities:
  1. To strategize and plan for Quality Assurance and Quality Control to achieve effective functioning.
  2. To lead strategic planning for continual improvement of GMP aspects in facilities, systems, and procedures.
  3. To oversee budgeting for Capital expenses and Operating expenses, manage departmental activities according to agreed budgets and timelines.
  4. To set goals for QA and QC, monitor, and guide them to complete Key Result Areas (KRAs), lead performance monitoring in relevant areas according to agreed standards, and take necessary action to communicate, advise, and assist based on performance levels.
  5. To collaborate across disciplines to maintain the Company's state of readiness for inspection by regulatory agencies, internal, and external auditors.
  6. To ensure timely responses against observations from Corporate Internal audits, Customer audits, Regulatory audits, and implement corrective, preventive actions on observations.
  7. To ensure the execution of Abbott Policies and Procedures at site.
  8. To drive continuous improvement at site with respect to Quality systems and processes.
  9. To conduct self-inspection, internal audit, and external audit as per schedule, plan, and regularly appraise the effectiveness and 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, 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 other applicable regulations and guidelines.
  14. To establish, approve, and reject starting materials, packaging materials, intermediates, bulk, finished products as per validated methods, Pharmacopeia methods, In-house Method for the site.
  15. To ensure Product recall is done as per site procedure and further coordination with Regional Quality for recall authorization.
  16. To ensure that Review Meet is conducted with senior management involvement to identify opportunities for continual improvement of products, process, and system.
  17. To ensure Quality Risk 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 patient protection.
  18. To approve documentation as applicable at site.
  19. To approve or 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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