Duration: Full Time/Contract
JOB DESCRIPTION:
- Knowledge Experience in Regulatory guidelines such as GAMPCFR and other FDA regulations LIMS experience should be good with regard to technical Processes to LIMS Very good communication skills
- Ensure compliance to industry standards like GAMP5 FDA 21 CFR Part 11 on electronic records electronic signatures etc
- Define Risk based strategies for validation of computerized systems and authorreview end to end Computerized Systems Validation documentation in accordance with Computerized Systems Validation Master Plan.
- Perform system risk assessments systems gap analysis review and approve action plans to ensure compliance during and after the system validation. Draft SOPs writing scripts for IQ OQ PQ and handling CSV Help guide and direct the project manager during the system implementation and validation process and ensure compliance with corporate policies and procedures.
- Provide training related to computerized systems validation quality and compliance to users and appropriate personnel.
- Experience in Internal Audit External Audit Face regulatory customer IT Quality System related inspections for all computerized systems.
- Responsible for review verification of Corrective Action Plan for audits Perform periodic review monitoring of computer systems implemented Proven experience in developing Master Validation Plan, validation scripts Validation reports all documentations required during CSV Implementation Process.
- CSV Experience in IT projects preferably in service based IT companies like TCS Infosys Wipro Cognizant etc.
- Knowledge of testing methodologies such as defect management test plan and test cases preparation Domain knowledge of pharma would be an added advantage
- Experience in tools such as HP QC Trackwise etc would be an added advantage
- Experience range for a resource from 2 to 6 years Experience range for Team Lead from 8 to 10 years