QA Officer

Quality HR Services

4 - 5 years

2 - 4 Lacs

ankleshwar

Posted:1 day ago| Platform:

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Skills Required

oos oot qms capa quality assurance production bmr ipqa document control gmp bmr review change control haccp qc fmea sop manufacturing api chemistry bpr documentation sampling data integrity quality management api manufacturing

Work Mode

Work from Office

Job Type

Full Time

Job Description

Responsibilities:

Ensure GMP compliant operations and robust Quality Management System (QMS) execution for API manufacturing at the Ankleshwar site, including documentation control, batch release support.
Batch Documentation & Release:
Review BMR/BPR, analytical reports, COAs; ensure compliance with specifications and data integrity (ALCOA+).
QMS Ownership:
Manage change controls, deviations, CAPA, OOS/OOT investigations with timely closure and impact assessment.
Documentation Control:
SOPs, specifications, STPs, protocols/reports; version control and archival as per GDP.
Vendor & Material Quality:
Support qualification, sampling, and release of RM/PM; review COAs and ensure traceability.
Training & Compliance:
Conduct/track GMP and GDP trainings; maintain training matrices.
Quality Risk Management:
Participate in risk assessments (FMEA/HACCP) and mitigation plans.
Change Implementation:
Partner with Production, QC, and Engineering to implement approved changes without compliance gaps.
Metrics & Reporting:
Maintain QMS KPIs; present trends to management.
EHS & Data Integrity:
Enforce site safety and DI requirements; escalate non-compliances.

Required Skills:

Must be excellent in written and spoken English; net savvy and adept at computer skills
Attention for detail
Team player
Good in communication

Required Qualification

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