Deputy Manager - Quality Assurance Piramal Pharma Ltd

5.0 - 9.0 years

0 Lacs

telangana

On-site

Preparation, review, and approval of investigation reports, risk assessment, impact assessment reports, and other required documents are key responsibilities in this role. You will handle product quality complaints (Adverse Event) related to Pharmacovigilance and market complaint investigations in CHEX system as per procedures, in coordination with the Pharmacovigilance team for adverse events. Additionally, you will manage the ENSUR system for the issuance and retrieval of SOPs, specifications, ATRs, worksheets, stability protocol management, BMR, BPR, BFR, as required. Ensuring document control, archival, retention, and destruction as defined in the procedure is crucial. You will also manage master and obsolete copies for SOPs, specifications, ATRs, worksheets, stability protocols, BMR, BFR, BPR, etc., and track SOPs, procedures, and specifications for revision as per the validity period. Archival management responsibilities include archival and retrieval of documents as needed. Your role will involve reviewing quality system documents such as protocols, reports, procedures, APQR, trend analysis reports, continual process verification reports, and sharing these documents with the RA department for filing updation based on change control implementation. Additionally, you will prepare and review customer and external audit compliance reports, as well as review and approve analytical reports like batch analysis, standards, stability studies, etc., and perform GMP verification and compliance reviews. To comply with safety, health, and environment guidelines, you must follow SHE Guidelines, SHE Rules, and Regulations, and use PPE wherever applicable. The qualifications required for this position include a Bachelor's Degree in Pharmacy/B.Sc/M.Sc/B.Tech in Chemical. In the three decades of its existence, Piramal Group has pursued a strategy of both organic and inorganic growth. Driven by core values, Piramal Group focuses on inclusive growth and ethical practices. Equal employment opportunity is a priority, where decisions are based on merit, qualifications, skills, performance, and achievements, ensuring equal opportunities for all. Piramal Critical Care (PCC), under Piramal Pharma Limited (PPL), is committed to delivering critical care solutions globally. PCC maintains a wide presence across the USA, Europe, and more than 100 countries worldwide, with a rich product portfolio that includes Inhalation Anaesthetics and Intrathecal Baclofen therapy. The team at PCC is dedicated to sustainable growth, with a global workforce spread across 16 countries, focused on expanding the global footprint through new product additions in the critical care space. Corporate social responsibility is a key focus, with collaborations and active roles in providing hope, resources, and care for the environment.,

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