Sr. QA Officer / QA Officer

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 (Must be from API Manufacturing Only)
Education: B.Sc / M.Sc (Chemistry) OR B.Pharm / M.Pharm
ERP Pharma Software Knowledge: Mandatory (Any ERP like SAP, BatchMaster, Tally ERP, Spectrum, Logic ERP, Pharma-specific ERP)
Gender: Male / Female (Preferred – due to shop-floor QA & shift activities)
Age Range: 28 – 40 Years
Salary Range: ₹3.00 LPA – ₹7.0 LPA (Based on skills, audit exposure, and ERP expertise)

Position Summary

We seek a highly skilled QA Officer / Sr. QA Officer with strong experience in API manufacturing quality systems, documentation control, GMP compliance, ERP pharma software, and regulatory support. The candidate must ensure strict quality oversight across production, documentation, audits, and compliance functions.

Key Responsibilities1. QMS (Quality Management System) Management

• Manage and maintain GMP / cGMP / ICH Q7 compliant systems.
• Handle Change Controls, Deviations, CAPA, OOS/OOT, Incident Reports.
• Ensure timely closure of all QMS activities with proper documentation.

2. Documentation Review & Control

• Review and approve MBR/MFR, BMR/BPR, SOPs, COAs, logbooks, specifications.
• Ensure issuance, revision, retrieval, and archival of controlled documents.
• Maintain real-time and accurate GMP documentation.

3. ERP Pharma Software – Data Entry & Documentation

(Mandatory Skill)

• Perform QA approvals, document controls, batch record checks in ERP.
• Manage material status, QC release, batch disposition, change controls via ERP.
• Maintain audit trails and data integrity using ERP modules.
• Ensure electronic document management and updated QA records.

4. Shop-Floor Quality Assurance

• Perform line clearance for production and packaging areas.
• Monitor compliance with GMP practices across all shifts.
• Oversight of sampling procedures for RM, intermediates & finished APIs.

5. Regulatory & Customer Audit Support

• Support audits from FDA, EDQM, WHO, TGA, MHRA, and customer audits.
• Prepare audit documents, responses, and implement corrective actions.
• Ensure audit readiness for internal and external inspections.

6. Validation & Qualification Support

• Review or approve validation protocols & reports:
• Process Validation
• Cleaning Validation
• Equipment Qualification
• Ensure compliance with quality and regulatory expectations.

7. Investigations & RCA

• Conduct or support investigations for:
• Deviations
• OOS / OOT
• Complaints
• Failures
• Use tools such as 5-Why, Fishbone Analysis, FMEA, QRM.

8. Training & Quality Culture

• Conduct training on GMP, GDP, documentation, data integrity.
• Promote “Right First Time” and continuous improvement in QA practices.

Required SkillsTechnical Skills

• Strong knowledge of API GMP, QMS, ICH Q7, data integrity.
• Expertise in batch documentation review & controlled document management.
• Hands-on experience with QMS activities (Deviation, CAPA, OOS, OOT).
• Solid ERP software usage capability in QA workflows.
• Basic understanding of analytical chemistry (HPLC/GC experience preferred).

Soft Skills

• Excellent communication & audit-handling ability.
• Strong documentation discipline and attention to detail.
• Effective coordination with Production, QC, Warehouse & R&D.
• Leadership qualities for senior-level role.

Experience Required

• Minimum 7–10+ years in Quality Assurance of API manufacturing plant.
• Must have experience in QMS, batch review, controlled documents, QA shop-floor.
• ERP pharma software experience is mandatory.
• Regulatory audit exposure preferred for Sr. QA Officer role.

Salary Range

₹3,00,000 – ₹7,00,000 per annum, depending on:

• Skill-set
• Audit handling experience
• ERP proficiency
• Level (Officer vs Sr. Officer)
• Previous CTC

Benefits may include:

• PF / ESIC
• Bonus
• Transport / Canteen facilities (if available)
• Yearly increments & performance incentives

Reporting To:

QA Manager / Head – Quality / Managing Director

Job Type: Permanent

Pay: ₹30,000.00 - ₹75,000.00 per month

Benefits:

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

Work Location: In person