Quality Control Specialist
The Quality Control Specialist will be responsible for the release of incoming goods, products for which production or packaging is outsourced, and products and processes in full compliance with quality procedures, legal guidelines, quality guidelines and market authorisation.
- 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 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.
Qualifications and Experience:
- This role requires a minimum of 3 years experience in Quality Assurance, Technical Operations or Engineering within the Biopharma / Pharmaceutical industry.
- The successful candidate will have strong contemporary knowledge of relevant cGMPs, regulations and current industry trends.