What are the responsibilities and job description for the Validation Process Engineer position at TekOne IT Services Pvt. Ltd.?
Key Responsibilities
- SOP Review: Review and approve Standard Operating Procedures (SOPs) and Administration Procedures related to filling lines.
- Documentation Approval: Review and approve functional and configuration specification documents for filling line design and configurations.
- Validation Lifecycle: Review and approve filling line validation lifecycle qualification documentation.
- Validation Documents: Review and approve key development/validation documents, including:
- Validation Plans
- User/Functional Requirement Specifications
- IQ/OQ/PQ Protocols and Reports
- Requirements Traceability Matrix
- Validation Summary Reports
- Change Control Evaluation: Evaluate change controls and associated risk assessments, ensuring compliance with quality plan objectives and milestones.
- Regulatory Compliance: Ensure adherence to applicable regulatory guidelines and GxP computer systems, including global electronic records/signatures regulations (21 CFR Part 11, Annex 11, etc.).
- Experience: Minimum 4 years of experience in:
- Filling Lines
- Pharmaceutical environments
- Validation processes
- CSV Automation
- Technical Knowledge:
- Strong knowledge of 21 CFR Part 11 principles.
- Solid background in cGMP and cGLP practices.
- Understanding of computer systems validation as outlined in GAMP or knowledge of System/Software Development Life Cycle concepts.
- Familiarity with domestic and international GMP regulations.
- Skills:
- Strong communication and project management skills.
- Ability to work in a fast-paced environment and engage effectively with management.
- Dependable, reliable, and professional demeanor.
- Demonstrated leadership ability in a dynamic organization.
- Integrity: Must demonstrate honesty, integrity, and compliance with the company’s code of conduct and regulatory standards.
