- Day to Day planning and execution of various activities in QA
- Execution/review/Approval & monitoring of process validation activities.
- Preparation, review, Approval of process validation Protocol/Report.
- Preparation, review and Approval of Annual Product Reviews
- Handling of Change Controls (Review, approval of scientific rationales)
- Handling of Deviation (Review, approval)
- Handling OOS (Review, approval)
- Handling of Market complaints, returned goods (Review, approval)
- Review of QC related events/incidents and invalid OOS (Review, approval)
- Handling of CAPA and tracking
- Handling queries of Customer & Regulatory Affairs
- Preparation, review and approve of various master documents (SOPs, Validation, etc.)
- Investigation of OOT (Review, approval)
- Preparation, Review and Approval of Cleaning validation protocol /report
- Vendor qualification activity
- Perform vendor onsite audit
- Review of Quality Risk management.
- Perform Self inspection.
- Conduct management review meeting
- Conduct training
- Preparation AMV protocols/reports, SOPs; FD study and other issuance part comes in QA.
- Record all data as per compliance and archive.
- Prepare the Regulatory related documents i.e.
Drug Master file and other regulatory
- required compliance documents if any as per requirements.
- Experienced in Regulatory affairs as well as valuable knowledge of quality assurance documentation work.
- Collect, collate and evaluate analytical data from a range of sources.
- As role of Quality assurance involvement is must plant inspections.
- Review company practices and work in line with company systems
- Prepare and keep online all track of quality related documents i.e BMR and other documents if any.
- Prepare & maintain online required documents for compliance.
- Facilitation in calibration of monitoring & measuring devices and maintaining all factory calibration records.
- As role of Quality assurance ensure that a company's products comply with the regulations of the regions where they want to distribute them.
- Any others related task assigned by reporting authority.
Required Skills:
- Have good communication skills.
- Logical Thinking
- Organizing