PM Group is looking to hire a Validation Specialist.
The key responsibilities of the Validation Specialist are as follows:
- Develop, review and approval of Validation SOPs, templates, guidelines , Validation Protocols and Reports including supporting site discrepancies and deviations investigation I closure in line with the policies and standards
- Ensure that all validation activities with respect to cleaning, sterilization, and facilities/equipment stated in validation plan/ protocol are carried out in accordance with relevant policies, standards, procedures and guidelines
- The qualification includes, FAT, SAT, IQ, OQ, PQ of any additional / modifications of existing manufacturing process facilities/equipment
- Lead investigations on discrepancies/deviation encountered during commissioning and qualification.
- Experience to creates, reviews and approve equipment qualification and analytical instruments lifecycle documentations, e.g. FAT, SAT, IQ, OQ, PQ protocols and reports, risk assessments, technical specifications.
- Experience in coordinate the commissioning and qualification activities (including the creation, pre-execution approval, execution, post-execution review, and post-execution approval of all validation lifecycle documents)
- Experience in leading daily validation meetings with cross functional in resolving validation issues.
- Experience in equipment qualification including analytical instrumentation and manufacturing equipment.
- Regular progress report of project deliverables to supervisor/project lead