FULLTIME
Executive/Asst. Manager - QA
Quality HR Services
Not specified · onsite · Posted 27d ago
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Undisclosed2–7 yrsfulltimeNot specified
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Section · 01
About this role
Job Summary
Position: Executive/Asst. Manager - QA
Location Location: Silvassa
Experience Experience: 2 - 10 Years
Industries Industries: Pharma
Responsibilities - Ensure compliance with GMP, regulatory guidelines, and quality standards in pharmaceutical formulation manufacturing.
- Manage quality systems, audits, documentation, validations, and batch release while leading the QA team.
- Implement and maintain Quality Management Systems (QMS) as per USFDA, WHO-GMP, MHRA, and EU-GMP.
- Oversee deviation management, CAPA, change control, and OOS/OOT investigations.
- Conduct and lead regulatory and customer audits and ensure compliance with audit observations.
- Manage process validation, cleaning validation, and analytical method validation as per regulatory standards.
- Maintain data integrity and ensure compliance in reviewing BMR, BPR, COA, and stability studies.
- Handle vendor qualification, supplier audits, and raw material compliance.
- Lead customer complaint handling, market recalls, and root cause investigations.
- Provide GMP training, mentoring, and development of the QA team to drive quality excellence.
- Ensure effective coordination with cross-functional teams to maintain quality standards across production and QC.
- Strong knowledge of regulatory compliance, quality risk management, and audit handling.
- Expertise in QMS, validation processes, and documentation review.
- Excellent leadership, problem-solving, and communication skills.
- Exposed to regulatory audits.
- Exposed with Sterile / Non-sterile products formulations.
- SAP is must
Required Qualification: B.Pharm/M.Pharm/B.Sc/M.Sc - Chemistry
Key Skills - Qa
- Manager
Sourced from naukri
Section · 02
Skills
bprcleaning validationAnalytical Method ValidationauditsChemistryDeviation ManagementCAPAChange ControlCustomer AuditsBatch ReleaseCommunication SkillsManufacturingcomplianceComplaint HandlingPharmaPharmaceutical
Section · Company
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
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4.6
Work-life
4.8
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