Quality Analyst

Quality Analyst - Head

• Team Leadership: Lead, mentor, and develop the QA team through training and performance reviews.

• Quality Management System (QMS): Establish and maintain a robust quality system, including SOPs, quality manuals, and other necessary documentation.

• Audits and Compliance: Conduct internal audits and prepare the site for external regulatory and customer audits. Ensure all activities adhere to GMP, GLP, and ISO guidelines.

• Documentation Review: Review and approve key documents, including batch manufacturing records (BMRs), batch packaging records (BPRs), specifications, Technical package, Stability protocol and validation documents etc. Review of drug substances as per compendial norms.

• Product Lifecycle Management: Oversee the release of drug substance, intermediates, and raw materials. Manage the investigation of deviations, out-of-specification (OOS) & out of trend (OOT) results, and market complaints, and ensure timely implementation of corrective and preventive actions (CAPA).

• Change Control: Manage the change control process to ensure that changes are properly evaluated, documented, and approved.

• Supplier Qualification: Oversee the qualification of raw material suppliers to ensure their compliance and the quality of incoming materials.

• Continuous Improvement: Drive continuous improvement initiatives within the quality department and across the organization.

Qualifications and skills

•* *Education: Typically requires a Bachelor's or Master's degree in Pharmacy (B.Pharm, M.Pharm) or Chemistry (B.Sc, M.Sc).

•* *Experience: 10-15 years of experience in a pharmaceutical QA or QC role, specifically within API or bulk drug manufacturing, is necessary.

•* *Technical Skills: Proficiency in quality management systems, GMP, validation, and a strong understanding of regulatory requirements is essential.

Job Type: Full-time

Pay: ₹70,000.00 - ₹120,000.00 per month

Work Location: In person