Your impact
Responsibilities include:
- Provide Quality management and oversight of the design and qualification activities;
- Develop and maintain the project quality activity plan;
- Drive the quality activities during the project execution phase from requirement setting, design through construction, verification and system release for process validation;
- Supporting the science and risk-based qualification and validation activities and agreeing best practices in line with applicable GMP Regulations;
- Support the execution and reporting of the commissioning, qualification, and validation activities;
- Prepare or review all documentation where required specific to quality activities;
- Ensure any deviations are thoroughly investigated and closed in a timely manner;
- Train project members in science and risk-based approach to validation.
Here's what you'll need
- Significant experience from a similar position within project execution the pharmaceutical or life-sciences industry;
- Strong experience with Commissioning, Qualification and Validation in project related activities i.e. Experience of the Validation lifecycle particularly the qualification of process equipment, utilities and HVAC associated within a Drug Substance facility;
- Strong experience in Validation to ensure compliance to Annex 15, EU regulations, applicable US FDA Guidelines and ASTM E2500;
- Strong experience of Computer System Validation regulations in line with 21 CFR Part 11, Annex 11 and Annex 15;
- Knowledge and understanding of EU and US cGMP regulations with respect to the validation, production and testing of pharmaceutical and/or biological products;
- Track record of utilizing Risk Based Approaches to Qualification / Validation activities;
- Strong track record of identifying, escalating and correcting compliance issues and implementing process improvements.
