QAV/ CQV Quality Specialist
This is a fantastic opportunity to be part of a fast-paced, €700 million project; with lots of opportunities to work with and learn about cutting-edge technologies, in addition to developing your own skills.
This is a truly exciting project, which when complete will contribute to the manufacturing of a life changing treatment.
Essential Duties and Responsibilities for this QAV role include,
- Support quality aspects of qualification and validation of equipment, facilities, and utilities associated with Manufacturing to ensure compliance with company policies, procedures and regulatory expectations.
- Will serve as the Quality SME for all validation activities across the site including but not limited to: Utility and equipment performance qualification, Steam in Place(SIP) & Cleaning Validation.
- Provide Quality oversight for Temperature mapping studies across Site Controlled Temperature Units (CTU’s). For example, standalone CTUs, Warehouse temperature controlled storage, Site Stability rooms.
- Support Validation of cleaning (CIP) cycles/methods/recipes for buffer and media preparation systems, upstream (bioreactors) and downstream equipment trains, parts washers and supporting process equipment.
- Input to Standard Operating Procedures (SOPs) and Work Instructions (WI) to enable suitable cleaning sampling activities to occur.
- Serve as a quality resource for assessing validation requirements, non-conformance, impact assessments, root cause analysis and implementation of CAPA found during CQV activities.
- Work closely with stakeholders and SME’s from site operations, quality operations, engineering & MS&T to provide quality oversight throughout the qualification and validation lifecycle.
- Support sustaining activities such as Change Management, Periodic review, Requalification, Site Cablibration Program
- Use of Quality Risk Management and Operational Excellence to promote continuous improvement.
- This role requires a minimum of 3 years experience in, Quality Assurance,Technical Operations or Engineering within the Biopharma / Pharmceutical industry.
- A self-starter and results-focussed, the successful candidate will have strong contemporary knowledge of relevant cGMPs, regulations and current industry trends.
- Experience working in regulated environment with exposure in the Regulations & guidance’s – GMP, CGMP, GAMP, 21 CFR Part 11
- Must have at least 3 years of experience in commissioning, qualification, and validation activities in in a regulated environment.
- Technical knowledge of Cleaning validation/verification, quality systems and regulatory requirements.
- Experience in review and approval of Cleaning Validation studies.
- Experience in review of temperature mapping studies. Ex CTU’s, Autoclaves, SIP systems.
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