Quality Assurance Manager

Company Description

EU GMP

Role Description:

Quality Control / Quality Assurance (QC/QA) Head

Responsibilities

• Establish and lead the QA and QC systems for an international regulatory-compliant facility (EU GMP, USFDA).
• Oversee raw material, in-process, and finished product testing as per pharmacopeial and regulatory standards.
• Develop and implement SOPs, quality manuals, and documentation systems as per global compliance norms.
• Prepare for and host audits by global regulatory authorities and international clients.
• Manage analytical validations, method transfers, equipment qualification, and process validations.
• Ensure timely review of COAs, BMRs, BPRs, deviations, OOS investigations, and CAPAs.
• Oversee stability studies, cleaning validations, and batch release activities.
• Lead the training and development of QA/QC teams on cGMP, data integrity, and regulatory updates.
• Collaborate with R&D, production, and regulatory teams to ensure compliance from development to commercialization.
• Maintain supplier and raw material qualification systems in line with international standards.

Qualifications

• Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, or related discipline.
• Minimum 8 years of pharmaceutical QA/QC experience, with at least 3 years in a leadership role.
• Prior experience in a 

  USFDA or EU GMP-audited facility

   is 

  mandatory

  .
• Excellent understanding of ICH guidelines, cGMP, and global regulatory requirements.
• Proficient in managing audits, technical documentation, and laboratory operations.
• Familiarity with solid oral dosage forms, especially DC granules, is preferred.
• Strong leadership, communication, and problem-solving skills.
• Hands-on experience with instruments like HPLC, UV, dissolution testers, etc.
• Proficiency in MS Office; experience with LIMS/QMS systems is an advantage.
• Willingness to be based full-time at our plant near Mumbai.