QA Manager

Job Description:

Position:        QA Manager

Location:        Ankleshwar

Experience:     15 - 18 Years

Industries:     Pharma - API

Responsibilities:

• 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 good 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

Required Qualification: -B.Pharm/M.Pharm/B.Sc/M.Sc - Chemistry

Salary :- Upto 21.00 LPA

 If you are interested for this opening please send updated resume on same mail with following details.

Total No. of Years Experience :-

Current CTC :-

Expected CTC :-

Notice Period :-