QA Analyst

We are seeking a detail-oriented and knowledgeable Quality Analyst to join our team in a leading pharmaceutical company. The ideal candidate will be responsible for ensuring that all products and processes comply with industry standards, regulatory requirements (e.g., GMP, FDA, WHO), and internal quality systems. The Quality Analyst will support continuous improvement and assist in maintaining a culture of quality throughout the organization.

Key Responsibilities:

• Quality Control Testing:
• Conduct routine and non-routine analysis of raw materials, in-process samples, and finished products.
• Perform chemical, physical, and microbiological testing in compliance with approved SOPs and regulatory guidelines.
• Documentation & Reporting:
• Maintain accurate records of test results, deviations, investigations, and quality metrics.
• Prepare Certificates of Analysis (CoA), stability reports, and analytical summaries.
• Compliance & Audits:
• Ensure adherence to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs).
• Support internal and external audits (e.g., US FDA, EMA, WHO, ISO) by providing relevant documentation and responses.
• Root Cause Analysis & CAPA:
• Participate in investigations of non-conformances and deviations.
• Assist in implementing corrective and preventive actions (CAPA).
• Cross-functional Collaboration:
• Work with production, R&D, validation, and regulatory affairs teams to ensure product quality throughout the lifecycle.
• Review batch manufacturing records and quality documents for release activities.
• Continuous Improvement:
• Contribute to quality improvement initiatives and support implementation of quality tools like QMS, 5S, and Lean practices.

Required Qualifications:

• Bachelor's or Master’s degree in Pharmacy, Chemistry, Biotechnology, or a related field.
• 1–5 years of relevant experience in pharmaceutical QA/QC.
• Sound knowledge of GMP, GLP, ICH guidelines, and regulatory frameworks (FDA, WHO, MHRA, etc.).
• Familiarity with analytical instruments like HPLC, GC, FTIR, UV-Vis, Dissolution testers, etc.
• Proficient in MS Office and laboratory data management systems (e.g., LIMS, QMS).
• Strong documentation and communication skills.

Job Types: Full-time, Permanent

Pay: ₹22,500.00 - ₹30,000.00 per month

Benefits:

• Health insurance
• Life insurance
• Paid time off

Ability to commute/relocate:

• Vasai, Maharashtra: Reliably commute or planning to relocate before starting work (Preferred)

Work Location: In person