About the Role

We are looking for a responsible and detail-oriented QA Executive / QA Chemist to join our pharmaceutical intermediates manufacturing facility. The candidate will be responsible for ensuring compliance with established quality systems, procedures and documentation throughout the manufacturing process.

Key Responsibilities

- Review and ensure compliance with Batch Manufacturing Records (BMRs) and other manufacturing documentation.

- Review QC analytical reports and ensure that results comply with approved specifications.

- Monitor manufacturing activities to ensure compliance with approved SOPs and quality procedures.

- Review and manage deviations, incidents and non-conformances.

- Assist in CAPA (Corrective and Preventive Action) investigations and implementation.

- Handle Change Control procedures and maintain relevant documentation.

- Review and maintain SOPs, specifications, formats and other quality documents.

- Coordinate with Production, QC and R&D; teams to investigate and resolve quality-related issues.

- Ensure proper documentation and traceability of raw materials, intermediates and finished products.

- Participate in internal audits, customer audits and regulatory inspections.

- Monitor implementation of GMP and good documentation practices (GDP) throughout the plant.





- Ensure proper handling and investigation of OOS/OOT results in coordination with QC.

- Maintain QA records and ensure timely closure of quality-related activities.

- Assist in implementing and maintaining the plant's overall quality management system.

Qualifications

- B.Sc. / M.Sc. in Chemistry preferred.

- Candidates with a degree/diploma in Pharmacy or relevant scientific discipline may also be considered.

- Relevant experience in pharmaceutical intermediates, API, specialty chemicals or fine chemicals will be preferred.

Experience

- 5 to 10 years of relevant experience in Quality Assurance.

- Experience in a pharmaceutical, API, pharmaceutical-intermediate or chemical manufacturing environment is preferred.

Desired Skills

- Good knowledge of GMP, GLP and Good Documentation Practices (GDP).

- Understanding of BMR/BPR review and batch release documentation.

- Strong documentation and analytical skills.

- Good understanding of quality systems and manufacturing processes.

- Ability to coordinate effectively with Production, QC and R&D; teams.

- Valuable communication and problem-solving skills.

- Strong attention to detail and ability to maintain accurate records

📌 Quality Assurance Lead (Solapur)
🏢 Levantex Pharmaceuticals
📍 Solapur