Muby Chem Hiring For Quality Assurance Department
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Muby Chem Hiring For Quality Assurance Department |
Opportunity in Gujarat (Ankleshwar)
Job Title – Head/Manager - Quality Assurance
Company Name – Muby Chem Pvt Ltd
Work Experience - Min 12+ years as QA in GMP
CTC- Not constraint for right candidate
Qualification – B. Sc./ M.SC./ B. Pharm/M. Pharm/or any other Related Qualification
JD of QA Manager
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.
Please mention the Job Title as subject and email your CV at hr@mubychem.com
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