- Candidate must be detail oriented as the main job responsibility is authoring in-house CSV documentation and review of documents provided by vendors.
- Experience in software development lifecycle processes (SDLC), Models, Standards in Pharmaceutical industry.
- Ability to prepare, review the end-to-end CS validation life cycle deliverables of Manufacturing (HMI, PLC, DCS based) & Lab equipments (GC-Empower, KF Titrino-Tiamo, UV & FTIR -Labsolutions, Stability Chambers-ICDAS etc..).
- Should have good exposure and hands on experience in CFR Part , EU ANNEX and GAMP guidelines and compliance requirements.
- Experience in leading (independently) validation for projects and ensure the compliance in systems maintenance activities like Data Backup & restoration, User access management, Audit trail review & periodic review etc.
- Candidate requires oral and written communication skills as there is a high degree of collaboration required between site stakeholders.
- Involve in QMS activities related to Computerized Systems and engineering department as applicable.
- Candidate must have the knowledge in validation of DCS & LIMS.
- Candidate should have good exposure in preparation of risk management process throughout the life cycle of Computerized systems.
- Comply with SHE Guidelines, SHE Rules and Regulations. Comply with usage of PPE wherever applicable.
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Executive Production
16 hours ago
Piramal Group Medak, India Full timeTo take & follow operating instructions for the shift activities from Shift-in-charge/Manager. · Ensure batch charging & other manufacturing operations should be strictly as per BMR/ SOP & in line with current GMP practices. · To maintain manufacturing records online & should com ...
Deputy Manager-QA - Medak, India - Piramal Group
Description
Key Roles & Responsibilities: