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Manager (Head) - Quality Assurance
ConfidentialIndore11 days ago
Job descriptionDevelop and implement a strategic vision for the QA function aligned with the company's overall business goals. Provide leadership and direction to the QA team, ensuring a consistent and integrated approach to quality management. Develop, implement, manage, audit and maintain GMP quality systems. Coordinate and perform all vendor qualification and compliance Should have well versed with handling of Regulatory Audits, APQR, OOS, OOT, Investigation, Laboratory Compliances, HVAC & Water Qualification & Validation, IPQA, Lab QA, Validation & Qualification and QMS. Develop, manage and maintain a GMP compliant document control system. Oversee investigations of all non-conformances (deviations, errors etc.). Ensure that cGMP requirements and quality standards are recognized, understood and maintained across the Company. Work across all disciplines (e.g. manufacturing, warehouse & QC, etc.) to ensure that the Company maintains a state of readiness for inspection by regulatory agencies. Collaborate with other departments, including Quality Control, Manufacturing, Warehouse, Engineering, R&D and Regulatory Affairs, to ensure a seamless integration of quality considerations throughout the product lifecycle. Lead, manage and ensure proper training to any relevant change management programs throughout the company. Maintaining and improving departmental operational performance, to meet the requirements of regulatory authorities, company Standard Operating Procedures (SOPs) and external and internal customers, with respect to quality, service, lead time and cost. Ensuring the development of departmental SOPs (writing, revising and approving), ensuring regulatory compliance in conjunction with being - fit for purpose- operationally and commercially. Ensuring that all activities are performed in accordance with GMP, company SOPs and Health and Safety policies. Ensuring that there is a self-inspection programme in place which is communicated to Operations to meet the requirements of CDSCO, WHO, GMP and other regulatory bodies. Stay abreast of global regulatory requirements and industry trends to ensure the company's compliance with cGMP, GCP, and other relevant standards. Oversee regulatory inspections and audits, implementing corrective and preventive actions as necessary. Establish and maintain robust quality systems, including document control, deviation management, CAPA programs, and change control processes. Develop and monitor key quality performance metrics to assess the effectiveness of quality systems and processes. Implement and oversee a robust supplier quality management program to ensure the compliance of Conduct supplier audits and manage relationships with key suppliers. Lead continuous improvement initiatives to enhance quality, efficiency, and operational excellence.
Preferred candidate profile
- Must have Bachler in Pharmacy (B. Pharma)
- Have Faced minimum 8-10 Regulatory Audits.
- Sound knowledge of CAPA, Deviation, Audit Management, Vendor Audit, Self-Inspection, Qualification & Validation, IPQA, QMS & Lab.
- Quality professional with 18 - 22 years of hands on experience with increasing responsibility in a QA function.
- Hands on experience implementing quality systems in a GMP environment, and direct experience with FDA and other health authority inspections.
- Extensive knowledge of various GMP compliances regulations and industry practices.
- Well-organized and detailed oriented professional, with strong verbal and written communication skills.
Skills Required
Validation, Qms, Ipqa, Qualification
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Quality Assurance Manager • Indore
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