Location: Fremont, CA
Start date: 10/01
Category : Full Time
- Involve in documentation of different stages of validation life cycle in compliance with 21 CFR Part 11.
- Responsible in analyzing business requirements, development of validation plans (VP),Validation Protocols (Installation Qualification, Operational Qualification and Performance Qualification), Requirement Traceability Matrix (RTM) and Summary Reports (validation and Test Summary Reports, VSR/TSR)
- Review and approval of corrective action and preventive action (CAPAs), laboratory investigations, protocols, forms and instructions to ensure compliance with cGMPs.
- Write protocols, execute commissioning and write Test Summary Report
- Responsible for developing and reviewing User Requirement Specifications (URS), Functional Requirement Specifications (FRS) and Design Specifications (DS).
- Design and develop the Requirements Traceability Matrix to track requirements.
- Review Validation deliverables to assure compliance with 21 CFR Parts 11 (Electronic Signatures & Records), 210, 211, 50, 56, 58 and FDA Regulations in the Software Development Life Cycle (SDLC).
- Check functionality of the system and executed scripts in validation environments by writing manual test scripts. Reviewed the scripts after formal validation.
- Involve in writing and editing Test Cases, Test Plans.
- Develop a Validation Plan by coordinating with the IT team to minimize the risks of data loss and verifying data integrity.
- Involve in developing and documenting Risk Assessments (RA’s) at high-level risk assessment (HLRA) and detailed FMEA (Failure mode and effects analysis)
- Involve in creation, maintain, summarize and review QA related documentation against quality document attributes, including but not limited to good documentation Practices, Completeness and Traceability, Coverage and Testability of System requirements, Accuracy, compliance risk mitigation and change management.
- Analyze the data in accordance with departmental policies and procedures to ensure it compliant with federal rules and regulations by using standard classification systems.
- Validate the Electronic Records and Electronic Signatures in accordance with the FDA Guidelines.
- Organize validation activities with related areas, samples collection, data analysis and Involved in the development of SOPs and validating laboratory equipment as per cGMP regulations
- Participate in CAPAs to solve manufacturing problems, explain process deviations, and change control processes
- Perform Gap Analysis and suggesting the Remediation Plans to mitigate the non-compliance.
- Able to use Enterprise Data Management platform Documentum tool for maintaining validation life cycle documents.
- Bachelor’s in Pharmacy or Equivalent is required
- 1-5 years relevant experience
- Strong technical writing to develop client SOPs
- Excellent communication skills
- Excellent attention to detail, analytical and problem-solving skills
- Experience in writing IQ, OQ and PQ protocols
- Knowledge of GMPs, GDPs, GLPs