Key Responsibilities of the Validation Manager
- To manage all operational validation activities within the client’s organization.
- To continue to develop and implement a compliant validation strategy for our client.
- Creating/Reviewing Validation documents across the Validation Life Cycle like Validation Plan, Protocols (IQ,OQ,PQ), Incident Report, RTM, Validation Summary Report
- GxP Regulatory Assessment, Risk Assessment, Validation Planning & Validation Reporting
Working with Test Management tools (HP ALM/Jira/Bugzilla)
- To continue to develop and implement an efficient compliant and cost effective calibration and maintenance program.
- To work closely with all departments and the Quality Department to ensure the operation of a validated environment according to GMP and other regulatory requirements
Skills & Qualifications:
At least 2 years of experience Validation Management experience ideally within the clinical, medical, laboratory or pharmaceutical industry.
Good understanding and application of GMP and regulatory requirements.
Good understanding of FDA regulations, 21 CFR Part 11, GxP requirements along with knowledge of GAMP, GDP
Good understanding of LS COTS products (Trackwise, Documentum, Veeva, LIMS, LMS, CTMS etc)
Experience of wide range of validations including Computer Systems Validation, equipment, cleaning and utility and facilities validation plans.
Excellent communication / interpersonal skills
Must possess formal training/certification on Testing & Validation
Excellent communication skills
Should be able to work independently with minimum supervision
Previously have managed or supervised a team of experienced engineers in a similar industry