Sr. Executive/Asst. Manager - QMS
Quality HR Services · Ahmedabad · onsite · Posted 28d ago
Undisclosed5–10 yrsfulltimeSourced from
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About this role
Job Summary
Position: Sr. Executive/Asst. Manager - QMS
Location: Ahmedabad
Experience: 5 - 12 Years
Industries: Pharma
Responsibilities - Ensure effective implementation of QMS requirements within the Production department.
- Prepare, Review, initiate, investigate, and monitor deviations, incidents, OOS/OOT, change controls, CAPA, and risk assessments related to Production.
- Coordinate with QA, QC, Engineering, Warehouse, and other cross-functional teams for timely investigation and closure of quality events.
- Review and ensure compliance of BMR/BPR, SOPs, logbooks, formats, and other GMP documentation.
- Support preparation and review of Annual Product Quality Review (APQR/PQR) data related to Production.
- Monitor CAPA effectiveness and ensure timely closure of commitments.
- Conduct and support self-inspections, internal audits, customer audits, and regulatory inspections.
- Ensure timely implementation of audit observations and track action plans to closure.
- Participate in QRM/FMEA activities for manufacturing processes, equipment, and quality risks.
- Identify opportunities for process improvement, compliance enhancement, and reduction of recurring deviations.
- Review production trends, deviations, yields, rejections, reconciliation, and other quality-related performance indicators.
- Ensure adherence to data integrity, ALCOA+ principles, GDP, GMP, and documentation practices.
- Provide GMP/QMS training to Production personnel and monitor training effectiveness.
- Support implementation and periodic review of SOPs, Work Instructions, Master Documents, and other controlled documents.
- Ensure timely investigation and closure of market complaints, product quality issues, and regulatory commitments related to manufacturing.
- Maintain QMS trackers, dashboards, and periodic management reports.
- Ensure effective implementation of change management and assessment of changes impacting product quality and regulatory compliance.
- Coordinate with QA for batch review, investigation closure, and product disposition-related activities.
- Promote a strong quality culture and right-first-time approach within Production.
- QMS
- GMP
- CAPA
- FMEA
- Root Cause Analysis
- 5 Why
- Risk Assessment
- BMR/BPR
- SOPs
B.Pharm/M.Pharm/B.Sc/M.Sc - Chemistry
Key SkillsSourced from naukri
Skills
market complaintsbprAPQRauditsChemistryCAPAChange ManagementCustomer AuditsFMEAManufacturing ProcessesAnnual Product Quality ReviewManufacturingcomplianceexcelPharmaCommunication And Interpersonal Skills
About Quality HR Services
Quality HR Services
Recruitment
30
employees
2017
9 years old
Vapi, Gujarat
India
₹3.1L PA avg
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