Quality Assurance Executive (Pithampur)

Quality Assurance Executive (Pithampur)

03 Oct
|
Speciality Organics
|
Pithampur

03 Oct

Speciality Organics

Pithampur

Job Description – Quality Assurance Executive

Position: Quality Assurance Executive
Experience: 4+ Years
Industry: Chemical / Pharmaceutical Manufacturing

Job Summary

We are looking for an experienced Quality Assurance Executive with a minimum of 4 years of relevant experience in a chemical or pharmaceutical manufacturing environment. The candidate will be responsible for quality documentation, BMR (Batch Manufacturing Record) preparation, review and compliance, process monitoring, deviations, CAPA, and coordination with Production and QC departments.

Key Responsibilities

- Prepare, review, and maintain BMR (Batch Manufacturing Records) as per approved procedures and specifications.
- Ensure proper completion and documentation of BMRs by the Production team.
- Review BMRs for completeness, accuracy, traceability, and compliance before batch release.
- Verify manufacturing and process parameters against approved specifications.
- Review and handle deviations, incidents, change controls, CAPA, and non-conformities.
- Coordinate with Production, QC, R&D;, Stores, and other departments for quality-related issues.
- Investigate quality deviations and support Root Cause Analysis (RCA).
- Ensure timely implementation and closure of CAPA.
- Review and maintain SOPs, specifications, formats, and other QA documents.
- Monitor compliance with established quality systems and procedures.
- Support internal, customer, and regulatory audits.
- Review analytical reports and coordinate with QC for product testing and batch release.
- Handle customer complaints and assist in investigation and corrective actions.




- Maintain proper documentation and data integrity as per company requirements.
- Ensure compliance with applicable GMP, QMS, safety, and regulatory requirements.
- Participate in quality improvement and process improvement activities.

Qualification

- B.Sc. / M.Sc. in Chemistry or relevant discipline
- B.Pharm
- Candidates with relevant QA experience in chemical/pharmaceutical manufacturing will be preferred.

Experience

- Minimum 4+ years of experience in Quality Assurance.
- Experience in BMR preparation, review, and documentation is mandatory.
- Experience in chemical/pharmaceutical manufacturing is preferred.

Required Skills

- Valuable knowledge of BMR/BPR documentation and review.
- Knowledge of GMP and QMS requirements.
- Good understanding of SOPs, deviations, CAPA, change control, and RCA.
- Strong documentation and analytical skills.
- Good communication and coordination skills.
- Working knowledge of MS Office.
- Ability to work effectively with Production and QC teams.

Key Responsibilities – BMR

- Preparation and issuance of BMRs as per approved master documents.
- Verification of raw materials, quantities, process parameters, and manufacturing instructions.
- Review of equipment, batch, and process records.
- Verification of critical process steps and in-process controls.
- Ensuring proper recording of yields, quantities, signatures, dates, and observations.
- Identification and reporting of documentation errors or discrepancies.
- Final review of completed BMRs before batch release.
- Ensuring proper archival and traceability of batch documentation.

Pay: ₹35,000.00 - ₹50,000.00 per month

Work Location: In person

📌 Quality Assurance Executive (Pithampur)
🏢 Speciality Organics
📍 Pithampur

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