Sr. QA Officer

1 day ago

Ankleshwar, Gujarat, India Palchin Chemicals Full time

JOB DESCRIPTION – QA Officer / Sr. QA Officer

Department: Quality Assurance (QA)

Industry: Pharma API Manufacturing

Location: Ankleshwar GIDC, Bharuch, Gujarat

Experience Required: 7–10+ Years ( Pharma API Manufacturing Only)

Gender: Male (Preferred – for shift & shop-floor responsibilities)

Age Range: 28 – 40 Years

Education:

  • B.Sc / M.Sc (Chemistry) OR
  • B.Pharm / M.Pharm

(Additional GMP/QA certifications preferred)

Position Summary

We are looking for a highly skilled QA Officer / Sr. QA Officer with strong exposure to API manufacturing, responsible for ensuring compliance with GMP, documentation control, process quality, regulatory requirements, and audit readiness at our Pharma API facility in Ankleshwar GIDC. Gujarat,

Key Responsibilities1. Quality Systems & Compliance

  • Implement and monitor GMP / cGMP / ICH / FDA guidelines in the plant.
  • Manage Change Control, CAPA, Deviations, OOS, OOT, Incident Reports.
  • Review and approve SOPs, MFR, BMR, BPR, logbooks, and controlled documents.
  • Ensure document control, including issuance, revision, retrieval, archival.

2. Shop-Floor QA Activities

  • Perform line clearance in API production and packing areas.
  • Monitor GMP compliance across all shifts.
  • Support process validation, cleaning validation, equipment qualification.
  • Review and oversee sampling procedures for RM, intermediates, and finished APIs.

3. Documentation & Batch Review

  • Review batch manufacturing and packaging records for completeness and compliance.
  • Ensure timely finalization and closure of batch records.
  • Verify COAs, analytical results, and stability documentation for APIs.

4. Regulatory & Audit Compliance

  • Support regulatory inspections (FDA, WHO, TGA, EDQM, customer audits).
  • Prepare audit documents, ensure audit readiness, and implement corrective actions.

5. Investigations & Root Cause Analysis

  • Conduct structured investigations for failures, deviations, and non-conformities.
  • Use tools such as 5-Why, Fishbone Analysis, FMEA, and QRM principles.

6. Training & Continuous Improvement

  • Train staff on GMP, documentation practices, data integrity, and SOPs.
  • Implement quality improvement and risk-reduction initiatives.

Skills RequiredTechnical Skills

  • Strong knowledge of API GMP, QMS, regulatory guidelines.
  • Experience in batch record review, OOS/OOT handling, and CAPA systems. ERP, CRM
  • Knowledge of analytical principles (HPLC, GC understanding).
  • Familiarity with process validation, cleaning validation, and QRM tools.

Soft Skills

  • Excellent communication and audit-handling skills.
  • Detail-oriented with strong documentation discipline.
  • Good leadership, coordination, and problem-solving ability.
  • Ability to work independently and cross-functionally.

Experience Required

  • Minimum 7–10 years QA experience mandatory in Pharma API manufacturing

(NOT acceptable: formulation-only experience).

  • Hands-on experience with customer and regulatory audits.
  • Experience in document control, batch release, deviation handling.

Salary Range

₹3,00,000 – ₹8,00,000 per annum (Based on skills & experience)

  • PF, Bonus, Performance Incentives
  • Canteen / Transport benefits (if applicable)

Reporting To

  • QA Manager / General Manager – Quality / Managing Director

Why Join Us

  • Growing and professionally managed Pharma API Manufacturing Company.
  • Strong focus on quality and regulatory compliance.
  • Opportunity for career growth to Assistant Manager QA.

Job Type: Permanent

Pay: ₹30, ₹75,000.00 per month

Benefits:

  • Food provided
  • Health insurance
  • Life insurance
  • Provident Fund

Work Location: In person

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