Manager Quality Assurance

Job Description

Job Overview The incumbent will be responsible to ensure that all external and internal processes and systems are followed before our product reaches our customers. You will be responsible for inspecting procedures and outputs and identifying mistakes or non-conformity issues. Qualification: B. Sc. / B. Pharm + M. Sc. /M. Pharm Experience: • 8 to 12 years in Quality Assurance • Thorough knowledge of methodologies of quality assurance and standards • Maintaining cGMP quality standards, ensuring stringent adherence to quality standards, norms & practices, identifying gaps & taking corrective actions. • Excellent numerical, communication skills and understanding of data analysis/statistical methods • Attention to details and Stake Holder management Roles & Responsibilities Process Documentation & Review • Ensure and review adherence to the processes and product quality through site documentation review -BMR/BPR -APQR -Monthly reports -IPQC data -Stability data - Validation Protocol/ Report • Preparing QA SOPs as applicable for TP sites and PEL CPD business and their effective implementation • To design, implement and ensure adherence to Quality Technical Agreement at Third Party Level • Review of Specifications and STPs applicable for Contract manufacturing sites. • Batch release, Ensuring timely analysis of batches and quality of products. • Review of Change control and Deviation at TP sites. • Handling Market complaints and carry out investigation and review, to find out the root cause for the complaint. • Handling of OOS results at contract manufacturing sites and carry out investigation to find out the root cause for the OOS observed. • Departmental SOPs preparation, implementation and Training of SOPs at Head Office. • Review of Specifications and STPs applicable for Contract manufacturing sites. • Review of Annual Product Quality Review of contract manufacturing products and improvement based on the identified Gaps. Process, System and Product Maintenance & Upgradation • Experience in quality standards and regulatory compliance: Implementation of quality system inline with current regulatory requirements. Ability to handle strategic planning by ensuring CMO governance, Gap analysis and risk mitigation documentation, product quality complaints investigation and recall handling. • Ensures Corrective and Preventive Actions (CAPAs) are implemented by CMOs and every task is performed in accordance with established SOPs • Training need identification and imparting Trainings at Contract manufacturing sites. • To upgrade quality system by ensuring tracking systems to monitor timelines and effective compliance to planned system. • Experience in Handling Technology Transfer (Analytical/ Process): Facilitate in transferring registration and relevant Quality document to CMO & ensure proper documentation of the transfer as per quality requirements