Responsibilities:
With energy and enthusiasm, the Quality Ops Deviation Specialist will:
- Will serve as a Quality SME for site deviation management system.
- Support the review and approval of site deviation and investigations reports.
- Ensure root causes have been identified and corrective action implemented and can demonstrate basic knowledge of six sigma, LEAN, and root cause analysis tools used for
- Day to day management of Deviation and CAPA metrics
- Support internal and external audit preparations regarding deviation management system
- support the delivery of site deviation training
- Support global meetings and activities for site deviation management system
- Works directly with cross-functional departments to ensure that quality system requirements are met.
- Performs other duties assigned by Management.
Qualifications and experience:
General
- This role requires a minimum of some 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 relating to deviation investigations and CAPA identification.
Technical
- 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 of deviation systems and investigations in a regulated environment.
- Must have experience of compiling and reporting QMS metrics.
- Experience with SAP desirable.
People
- 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.
If you would like to hear a little bit more about it, please email me your CV to [email protected] or apply in the link below.
