- Develop 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 Operation

📌 Manager (Head) - Quality Assurance (Indore)
🏢 Alembic Pharmaceuticals
📍 Indore