We've just been engaged by the market leader in transdermal therapeutic systems & oral thin films to assist with a brand new role within their Quality Technical Services department, a QTS Validation Specialist, to perform activities associated with Equipment IQ,OQ,PQ’s and Calibrations, Validation Protocols and Reports.
- Performs activities associated with Equipment IQ,OQ,PQ’s and Calibrations, Validation Protocols and Reports
- Writes Validation Protocols and Reports.
- Support Equipment Qualifications and Calibrations
- Plan and coordinate cleaning, manufacturing processes, facilities and equipment validation activities. Support cleaning evaluations and verifications.
- Develop validation plans and schedules.
- Interact directly with customer on cleaning assessments, deviations, and validation strategy for assigned projects.
- Coordinate validation activities with heads of Manufacturing and Converting/Packaging.
- Assess regulatory impact of deviations, changes to equipment and batch records, materials and calibrations from validation perspective.
- Analyze data and work with Project manager to solve technical problems.
- BS in Scientific discipline or equivalent.
- 4-5 years’ experience in the Pharmaceutical Industry with minimum 3 years’ experience in experience in cleaning validation, manufacturing processes, equipment and facilities validations.
- Knowledge of validation concepts and current cGMP (21 CFR Parts 210/211, Part 820 & Part 11, ICH)
- Experience in data compilation and review for statistical evaluation.
- Demonstrated experience in writing and reviewing validation reports.
- Strong computer and interpersonal skills.