Executive / Assistant Manager- Operational Quality-3

Job description

Business IntroductionWe manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance.Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it’s vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply.We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients. Position SummaryThis role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: • Ensure GMP adherence through independent oversight of GMP processes and proactive quality culture. • Provide first-line QA support to operations, including rapid response, guidance, coaching, and maintaining inspection readiness. • Ensure right-first-time line clearance and shop-floor compliance with regulatory and QMS requirements. • Perform SAP (dMERP) transactions related to batch release, QA activities, and batch status tracking and communication. • Review and approve GMP documentation including BMRs, MFRs, SOPs, MRNs, rejection records, and related quality documents, ensuring ALCOA+ compliance. • Lead or support investigations of deviations and quality events, ensuring timely closure of CAPAs, deviations, and quality actions. • Conduct quality audits, oversight checks, spot inspections, risk assessments, gap analyses, and management monitoring activities across GMP areas. • Provide real-time QA support, guidance, coaching, and quality decision-making during manufacturing operations and quality escalations. • Support internal, customer, and regulatory inspections, validation activities, stability programs, and implementation of quality improvement initiatives. • Identify, assess, escalate, and mitigate quality and compliance risks while ensuring facilities and operations maintain required standards. • Promote a proactive quality culture by driving Quality Starts with Me (QSWM), GPS initiatives, employee capability building, and continuous improvement programs.  Why You?Work model: This role is on-site in India. Regular presence on the production floor and active participation in cross-functional meetings are required. We welcome applicants who bring curiosity, honesty and a practical focus on quality and patient safety. We are committed to inclusion and encourage people from different backgrounds and experiences to apply. Basic QualificationWe are seeking professionals with the following required skills and qualifications to help us achieve our goals: • Bachelor/ Master’s degree in pharmacy, or life sciences, chemistry, biotechnology or equivalent • Minimum 5-8 years’ experience in Good Manufacturing Practice (GMP)/ Quality Management System operations or quality assurance in a regulated manufacturing environment. • Practical knowledge of GMP and quality management systems. • Experience participating in investigations, deviations and CAPA activities. • Reasonable knowledge of Drugs and Cosmetics Act + Schedule M and acquaintance of international regulatory expectations. • Good communication skills in English and ability to work with cross-functional teams. Preferred QualificationIf you have the following characteristics, it would be a plus: • Master’s degree in pharmacy, life sciences, chemistry, biotechnology. • Experience with advance computer skills, electronic batch records, manufacturing execution systems or SAP quality transactions. • Prior participation in internal or external audits and inspection readiness activities. • Familiarity with root cause analysis and continuous improvement tools. • Experience of leading and supporting quality improvement projects. • Knowledge of Indian and international regulatory requirements relevant to manufacturing and distribution. What you will bring • A practical, solutions-focused approach and attention to detail. • Honest and accountable behavior with patient safety at the Centre. • Willingness to learn and grow through coaching and cross-functional collaboration. • The ability to work at pace while balancing rigor and risk. Ready to apply?If this role feels like the right next step for you, please apply. Tell us briefly about a quality challenge you helped resolve and what you learned. We look forward to learning how you can contribute and grow with us. Skills Data Integrity, Detail-Oriented, Digital Fluency, GxP Regulations, Influencing Without Authority, Lean Management, Pharmaceutical Regulatory Compliance, Problem Solving, Quality Assurance (QA), Risk Awareness, Technical Writing    Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahea