Executive - Quality Assurance Piramal Enterprises

5.0 - 9.0 years

0 Lacs

maharashtra

On-site

As a Validation Specialist at Piramal Pharma Solutions, your primary responsibility will involve preparing and updating various validation documents to ensure compliance with regulatory requirements. This includes developing Validation Master Plans (VMP), Process Validation protocols, Computer System Validation protocols, and reports. You will also be responsible for creating product matrices, Cleaning Validation/Verification protocols, qualification/requalification protocols for equipment/instruments, utilities, and facilities, as well as area validation protocols and reports. In addition to validation activities, you will be involved in quality risk assessments, review of calibration certificates, issuance and archival of Batch Manufacturing Records (BMR) and Batch Packing Records (BPR), preparation of Annual Product Quality Review (APQR), line clearance for manufacturing, packing, and dispensing activities, sampling of bulk and finished goods, and review of production records. Furthermore, you will play a key role in managing change controls, deviations, and CAPA (Corrective and Preventive Actions), conducting complaint handling, updating departmental SOPs, providing training as per schedule, coordinating training programs with HR, and ensuring documentation management as per SOP. You will also be responsible for providing necessary documents/data to meet internal and external quality, environmental, health, and safety requirements. Moreover, you will be involved in compliance monitoring through self-inspection programs, audit compliance coordination, preparation of responses to audit reports, and execution of food/dietary supplements regulations for export markets. You will also oversee the implementation of sanitation programs, adherence to EHS norms, and various corporate initiatives. Piramal Group values equal employment opportunity, ensuring that all applicants and employees are treated fairly based on merit, qualifications, skills, and performance. As part of a globally integrated network of facilities, Piramal Pharma Solutions offers a wide range of services across the drug life cycle, making it a trusted partner for innovators and generic companies worldwide.,

Posted 1 month ago

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