Team Member -IPQA (Isolator mandatory)

About the Role

We are seeking a dedicated and detail-oriented Team Member – IPQA (Isolator Mandatory) to join our Quality Assurance division at our pharmaceutical manufacturing facility in India. This role is critical to ensuring that all in-process quality checks and compliance activities are carried out in strict accordance with regulatory standards and Good Manufacturing Practices (GMP). The successful candidate will work within a highly controlled environment, operating isolator technology to maintain product integrity and sterility throughout the manufacturing process. This is an excellent opportunity for a quality-focused professional to contribute to the production of life-saving pharmaceutical products while advancing their career in a world-class manufacturing environment.

Key Responsibilities

• Perform in-process quality assurance (IPQA) checks and inspections during manufacturing operations, ensuring all activities comply with established SOPs, GMP guidelines, and regulatory requirements.
• Operate and monitor isolator systems during aseptic processing and filling operations, adhering strictly to contamination control protocols and safety procedures at all times.
• Conduct line clearance activities before and after batch manufacturing, verifying that equipment, materials, and documentation meet all specified quality standards prior to production commencement.
• Review and verify batch manufacturing records (BMRs), batch packaging records (BPRs), and other critical documentation to ensure accuracy, completeness, and full traceability throughout the production cycle.
• Identify, document, and report deviations, out-of-specification (OOS) results, and non-conformances, initiating appropriate corrective and preventive actions (CAPA) in a timely and thorough manner.
• Collaborate closely with production, microbiology, and regulatory affairs teams to investigate quality issues and implement robust solutions that prevent recurrence and protect product quality.
• Participate in internal audits, self-inspections, and regulatory audits, providing accurate data and supporting documentation as required by auditing bodies including USFDA, WHO, and CDSCO.
• Maintain up-to-date knowledge of current industry regulations, pharmacopoeial standards, and best practices related to aseptic manufacturing and isolator technology.

Requirements

• Bachelor's degree in Pharmacy (B.Pharm), Science (B.Sc. – Chemistry, Microbiology, or Life Sciences), or a related discipline from a recognised institution.
• Minimum 2–4 years of hands-on experience in an IPQA role within a pharmaceutical manufacturing environment, with mandatory experience working with isolator systems.
• Strong working knowledge of GMP, GDP, and relevant regulatory guidelines including Schedule M, ICH guidelines, USFDA, and WHO standards applicable to sterile and non-sterile manufacturing.
• Proficiency in reviewing and maintaining quality documentation such as BMRs, BPRs, deviation reports, change controls, and CAPA records with high accuracy and attention to detail.
• Demonstrated ability to operate within a cleanroom environment and comply with stringent gowning, hygiene, and contamination control requirements as mandated by site SOPs.
• Excellent analytical, problem-solving, and communication skills with the ability to work effectively both independently and as part of a cross-functional team in a fast-paced environment.
• Familiarity with electronic quality management systems (eQMS) and data integrity principles as per regulatory expectations is considered a distinct advantage.

Benefits

• Competitive compensation package with performance-based incentives aligned to industry benchmarks and individual contributions.
• Comprehensive health and wellness benefits including medical insurance coverage for employees and their immediate family members.
• Structured learning and development programmes, including access to GMP training, regulatory updates, and opportunities for career advancement within the organisation.
• Provident Fund (PF), Gratuity, and other statutory benefits as per Indian labour law, ensuring long-term financial security for all permanent employees.
• A collaborative, inclusive, and safety-first workplace culture that values quality, innovation, and the professional growth of every team member.