Assistant Manager OQ - Batch Release & Engineering Oversight

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Business Introduction We 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 Summary The incumbent is accountable & responsible for Review of Batch documents & Batch release in accordance with GSK QMS & applicable regulatory requirements and acts as the first contact point for any Quality issues in area of operation. To improve the effectiveness of quality in preventing, identifying and addressing quality issues by encouraging proactive quality culture and continuous improvement. To maintain presence and be accountable for key quality decision-making or quality escalations. To provide first line support to Engineering & Utilities areas and maintain inspection-readiness through independent checks. Key Responsibilities (Key deliverables, specific duties, any specialist duties and the ongoing responsibilities of the role) Ensures compliance and inspection readiness. Ensures release of bulk and finished products, meeting the statutory and QMS requirements, to market. BMR & BPR review and subsequent compliance review, Analytical report review and CPP trending Handling of dMERP (SAP) system related to batch release and other QA transactions to enable batch release process is followed as per SOP. Ensures that the manufacturing & packing operations on shop floor are in compliance with regulatory and QMS requirements. Ensures support provided for timely compliance to all audit observations in the area. Reviews Master BMR / draft MFR of products manufactured and packed in area of operation as per regulatory requirements and SOPs. Supports internal QMS activity for Engineering, Warehouse, Administration, PR&D,EHS,HR,Validation,L&D and Planning. Supports implementation of Quality Improvement Plan for Quality department. Support closure of deviations and investigations. Supports/conduct Self Inspection audit as per schedule. Support for internal and regulatory inspections Maintain presence across area of responsibility and be the first line of contact to support initial management of quality issues and be accountable for key quality decision making across activities such as the initial impact assessment for deviations. Provide guidance during GMP activities to proactively detect potential quality issues through active observation in real-time, allowing for timely interventions to prevent deviations and defects at Engineering & Utility areas Ensure adherence to frequency of oversight mandated in the Quality oversight schedule at Engineering & Utility areas and production areas. Foster a Quality Starts With Me (QSWM) culture by providing coaching to employees on the importance of following procedures, doing the right thing and explaining the why and the impact non-compliance can have on product quality and patient safety at Engineering & Utility areas. 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, integrity, 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 Qualification We are seeking professionals with the following required skills and qualifications to help us achieve our goals: Minimum Level of Education - B. Pharm / B. Sc./ M. Pharma / M. Sc. Area of Specialization - Pharmacy / Chemistry Why is this Level of Education Required? - To ensure the Batch Release procedure with QMS & Regulatory requirement. To ensure Operational Quality oversight across production, and related service areas. (Preferred Level of Education - Masters) Area of Specialization - Science/Pharmacy Minimum Level of Job-Related Experience required - 7 to 10 years Why is this Level of Education & Experience Required? - Capability to understand Regulatory, QMS & Site Batch release SOP requirement indetail. Preferred Qualification If you have the following characteristics, it would be a plus: Knowledge of Regulatory & QMS Requirements Good knowledge of computer software (Word, Excel and Power Point) Good interpersonal, Excellent oral and written communication skills

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