•Support quality aspects of qualification and validation of drug substance production 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: Upstream, Downstream and site systems.
•Provide Quality oversight to Upstream manufacturing activities as part of facility start up.
•Input to site operations Standard Operating Procedures (SOPs) and work instructions (WI).
•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 Deviation and Change Management.
•Use of Quality Risk Management and Operational Excellence to promote continuous improvement.
•Bachelor’s degree (or higher) in Engineering, Chemistry, Biology, or relevant discipline, the successful candidate will also ideally have a proven track record in delivering excellence.
•This role requires a minimum of 3 years’ experience in, Quality Assurance, TechnicalOperations or Engineering within the Biopharma / Pharmaceutical 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 a 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 a regulated environment.
• Technical knowledge of Cleaning validation/verification, quality systems and regulatory requirements.
• Experience in review and approval of Cleaning Validation studies.
• The motivation to be an inspiring member of a high performing team.
• The desire to continuously learn, improve and develop.
• A great communicator, decisive decision maker and proven ability to deliver excellence.
• Confidence to direct off-site suppliers to the project, willingness to support the team and a laser light focus to deliver excellence.
• Strong contemporary knowledge of relevant cGMPs, regulations and current industry trends.
• Experience with new product introductions and/or process qualification/technology transfer
• Detail oriented and meticulous worker
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