Computer Systems Quality Lead (Astral SteriTech)
Centrient Pharmaceuticals Netherlands, India
Job Description
Reporting to the Corporate CSV Manager and providing services to the Astral SteriTech Pvt Ltd: Ensure compliance with Data Integrity best practice and maintain the validated state of local GxP systems (e.g.: DCS, PLC, SCADA, Empower, Analytical Instrument Workstations) according to applicable regulations and Corporate Policy and Procedure.
Comply with cGMP as meant by CFR part 11, EU GMPs Annex 11. Ensure embedding of Quality and Validation in the total site approach, thinking and acting. Coach and train direct colleagues as well as Key-Users. Defines Owns local site CSV processes and procedures, monitors CSQ Risks and ensures compliance, reports on risk mitigation plans and compliance to Corporate QA and local site leadership. Is the key contact for auditors.
Key Individual Accountabilities
- Establish and maintain the CSQ (CSV amp; DI) Quality System.
- Responsible for maintaining and Developing CSV, Quality Management System Framework This includes responsibility to : oDevelop/refresh of CSV-related SOPs, Guidelines, Standards, Templates and Training materials to the agreed timescales for Global Compliance. oConduct in-depth monitoring reviews, provide assurance that business controls align with regulatory requirements and implement effective regulatory risk control
- Maintains GMP systems in validated status by coordinating validation activities and ensuring timely issuance of validation documents.
- Executes Change Control governance in line with processes and stakeholders such as QA, Engineer, etc
- Acts as System Subject Matter Expert on systems Quality and Validation.
- Organize trainings on CSQ processes.
- Define and maintain the GMP compliancy audit agenda for the Qualified Vendors. •Coordinate the Periodic Reviews on GxP systems.
- Participates in projects.
- Owns related local quality improvement projects.
- Lead Data Integrity Project at the site
Key Shared Accountabilities
- Participate in relevant teams for all CSQ and core business process projects to ensure that the necessary validation activities are identified and carried out.
- Participate and provide leadership and technical SME to site CSV and DI improvement projects.
- Participate in Corporate Audit( Virtual and On site) and for Computerized System
- Provide IT CSV support for agency audits including multiple international agencies at one time.
- Cross pollinate specialist knowledge to other Centrient sites.
- Collaborate and contribute to global initiatives.
Requirements
- University degree in technical, science, chemical engineering or computer sciences
- 5 - 12 years experience within CSV / DI and Pharmaceuticals.
- Working knowledge of process automation and Server / Workstation based systems.
- Strong Quality and continuous improvement mindset.
- Deep expertise in Computer System Validation and Data Integrity for the Pharmaceutical industry.
- Independent and reliable worker
- Strong communications skills.
- Good Knowledge of GxP Analysis, Gap Assessment and 21 CFR Part 11 of USFDA in Validation. •Good Knowledge of spreadsheet Validation