Are you a skilled Quality Validation specialist wanting to take the next step in your career?
INCOG Biopharma Services is offering this exciting role to enable the right mind to join them in contributing towards a better path to market for life-saving drugs. Having recently been voted as one of the Best Places To Work in Indiana for the second year in a row, INCOG is the perfect place to continue building your career.
This role involves engaging directly with the Sr Quality Engineering Validation Manager, and will aid in the implementation of quality procedures and standards throughout all stages of manufacturing, packaging, release.
Main aspects of the role include:
- Review and approve documentation for compliance and quality approval- protocols, summary reports, and change controls relating to equipment and software commissioning and life cycle updates, IQ/OQ/PQs, cleaning validations, and process validations
- Provide Quality oversight for the periodic qualification evaluation (PQE) program to ensure timeliness of execution and documentation completion
- Analyze and track deviations and identify sources of variability and error site processes using applied statistics and other technical skills
The ideal candidate will have a Bachelor’s degree in a related scientific field (or appropriate industry experience), as well as a minimum of 5 years of commissioning, qualification, and validation (CQV) experience within the biopharma industry. Having experience with CQV activities for aseptic/clean room facilities would be an added advantage.
Don’t meet all the requirements? Don’t sweat! We’re always looking for an excuse to discuss your next opportunity. You might just surprise yourself…
Lead Candidate wholeheartedly supports Equality and Diversity in employment and opposes all forms of unlawful or unfair discrimination on the grounds of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.