Asst. Manager - QA
Quality HR Services · Not specified · onsite · Posted 27d ago
Undisclosed8–13 yrsfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
Position: Asst. Manager - QA
Location: Daman
Experience: 8 - 15 Years
Industries: Pharma
Responsibilities - To maintain a robust Quality Management System (QMS) aligned with regulatory expectations.
- To handle internal, external, and regulatory inspections, ensuring successful outcomes and continuous compliance readiness.
- To handle compliance of deviation management, change control, Market Complaint Recall, CAPA systems, OOS, risk assessments, and investigations with regulatory and quality standards.
- To manage cGMP/GLP/GDP/GEP followed by all personnel.
- To manage batch release processes, ensuring timely review and disposition in alignment with GMP requirements.
- To manage document control, master batch records, validation protocols, and ensure timely periodic reviews.
- To manage continuous improvement initiatives to enhance the Quality Management System (QMS) and drive operational excellence.
- To manage timely review and approval of Batch Manufacturing Records, Quality Control (QC) reports, and Certificates of Analysis (COA).
- To execute QA release for commercial and validation batches, including product quality review and compliance verification.
- To led training programs on GMP, GDP, Data Integrity, and regulatory updates for QA and cross functional teams.
- To manage quality culture across the site through continuous learning initiatives and behaviour- based quality systems.
- To collaborate with Engineering, Quality Control (QC), Regulatory Affairs, Supply Chain, andCorporate Quality teams to ensure smooth execution of compliance activities and alignment with regulatory quality standards.
- To manage Quality Risk Management (QRM) activities, including risk assessments and mitigation planning to proactively identify and address quality and compliance risks.
- To manage effective coordination with validation teams for timely execution of equipment qualifications, re-qualifications, and periodic reviews of OSD manufacturing equipments and
- Injection manufacturing equipment like Autoclave, Tunnel, Vial washing machine, Filling machine, Human Resource and Administration Department Lyophilizer, Isolators and utilities like HVAC systems, Nitrogen, compress air, water system, pure steam.
- To manage Process Validation, Cleaning Validation activities and Aseptic Process simulation compliance to ensure alignment with current regulatory expectations and cGMP standards.
- To review and approval of Qualification Protocols, Validation Reports, SMF, and VMP to ensure compliance with regulatory standards.
- To led and actively participate in external regulatory audits and customer audits, serving as a key point of contact for quality and compliance matters.
- To demonstrate strong audit-facing capabilities with a proven track record in managing regulatory and customer audits, ensuring timely and effective closure of observations through robust CAPA implementation.
- To accountable for in-process Quality Assurance (IPQA) activities across Liquid Injectable, Lyophilized Injectable, and Solid Oral Dosage manufacturing and packing areas.
- To ensure adherence to current Good Manufacturing Practices (cGMP) by proactively monitoring operations and resolving day-to-day quality and compliance issues in real time.
- To ensure timely review and approval of key quality documents including Annual Product Quality Reviews (APQRs), Continued Process Verification (CPV) reports, and implementation of CAPAs where required.
- To oversaw accurate stability monitoring programs in compliance with ICH guidelines andcustomer-specific requirements.
- To accountable for release or rejection of raw materials, packaging materials, intermediates, and finished drug products as per approved procedures.
- Logical thinking.
- Organizing.
- Good communication.
B. Pharm/M. Pharm
Key Skills - qms
- Capa Systems
Sourced from naukri
Skills
cleaning validationCGMPHVAC systemsauditsIsolatorsDeviation ManagementCAPAChange ControlIPQABatch ManufacturingAutoclaveFilling MachineCustomer AuditsBatch ReleasecpvManufacturingAdministrationHVACcompliance
About Quality HR Services
Quality HR Services
Recruitment
30
employees
2017
9 years old
Vapi, Gujarat
India
₹3.1L PA avg
Avg at Quality HR Services
About
Quality HR Services
Industries
Recruitment
Employee ratings
10 reviews
4.9/ 5
Culture
4.7
Career growth
4.6
Work-life
4.8
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