You should have a minimum of 3-4 years of experience in pharmaceutical Commissioning, Qualification, and Validation (CQV). Your responsibilities will include: - Authoring commissioning protocols for equipment and utilities like Reactors, centrifuges, dryers, HPLC, etc. - Coordinating with engineering and Original Equipment Manufacturers (OEMs) for Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT). - Developing documents such as Design Qualification (DQ), System Impact Assessment, and Risk Assessment in collaboration with OEMs. You will also be required to: - Create, review, and execute qualification protocols including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for process equipment. - Ensure that qualifications are conducted in compliance with regulatory standards such as FDA and WHO. Additionally, you should possess: - Proficiency in good documentation practices and Quality Management System (QMS) processes throughout the CQV lifecycle. - Ability to collaborate with various teams including engineering, manufacturing, Quality Assurance/Quality Control (QA/QC), and Information Technology (IT) to facilitate CQV activities and ensure project success. - Provide technical insights during project planning and scheduling of CQV tasks. - Monitor and communicate the progress of CQV milestones effectively. - Strong project management skills and exceptional communication and writing abilities.,
As a Plant IT Pharma (GxP Compliance) in Bangalore within the Information Technology / Manufacturing IT department, you will have the following key responsibilities: - Manage all IT operations at the manufacturing plant, ensuring alignment with corporate IT standards and regulatory requirements. - Provide GxP-compliant support for manufacturing systems (MES, LIMS, SCADA, etc.) and ensure proper documentation and validation protocols are followed. - Act as the primary IT contact for plant and quality assurance teams. - Support audits and inspections by regulatory bodies (FDA, EMA, etc.) by providing required documentation and demonstrating compliance. - Manage local infrastructure (servers, networks, desktops, printers) and coordinate with central IT teams for enterprise-level support. - Implement and monitor cybersecurity protocols in the plant environment. - Coordinate the rollout of new IT systems and upgrades while ensuring minimal disruption to manufacturing operations. - Maintain and update IT SOPs in compliance with GxP standards. - Collaborate with vendors and third-party service providers for support and maintenance of plant systems. - Train and support end-users on relevant IT systems and best practices. Qualifications & Skills: - Bachelor's degree in computer science, Information Technology, or related field. - 3+ years of IT experience, with at least 2 years in a pharmaceutical manufacturing environment. - Strong knowledge of GxP, 21 CFR Part 11, and other applicable regulatory requirements. - Experience supporting or managing systems such as MES, LIMS, SCADA, or ERP in a GMP environment. - Familiarity with ITIL processes and system validation life cycle (SDLC). - Strong troubleshooting, analytical, and communication skills. - Ability to manage projects and coordinate cross-functional teams. - Experience with audit readiness and participation is a strong advantage.,