We are looking for a Quality Compliance Officer, a position based in a QA Team which is responsible for the management of the non-conformance and CAPA systems to support the manufacturing and testing of pharmaceutical products to GMP, the management of change control and risk management systems, the management for the internal and supplier audit management programmes, the management of the product review process the management of QA environmental compliance and the provision of QA oversight of manufacturing and testing activities.
As the Quality Compliance Officer you will support an In Process Team assigned to a particular manufacturing process. You will support a team by performing all duties associated with the
release of products in a compliant and timely fashion.
Some key responsibilities include:
- Support the co-ordination and planning of the IPT workload, ensuring Quality matters
are considered and acted upon in a compliant fashion.
- Actively participate in Quality investigations, change controls and risk assessments
associated with the IPT to ensure Quality considerations are taken into account.
- Facilitate and lead structured investigations using recognised models such as “5
Whys” and “FMEA”.
- Perform the review and approval of a number of key documents associated to the
IPT including but not limited to: validation, SOPs, change controls, investigations, risk
assessments, pre manufacturing checks, facility release.
- Perform review of batch manufacturing records and release relevant material for the
next stage of manufacture.
- Provide appropriate QA oversight of manufacturing and testing processes within the
IPT to support the business (including occasional out of hours).
- Participate in the data gathering/review for the quarterly trending reports and annual
PQR for the related stage of manufacture
- Provide training and coaching to more junior members of the team and to staff from
other departments in order to promote a quality culture.
- Liaise with customers, consultants and contractors as required.
- Escalate relevant issues to line management and/or to the QP.
- Provide KPI reports measuring the performance of the team.
- Undertake relevant training.
We are looking for a candidate who is educated to at least degree level in a relevant subject (microbiology/biotechnology) or equivalent qualification/experience. You will need to have gained significant experience in the Pharmaceutical Quality Assurance, as well as practical experience in change management, risk management, non conformance, batch release and QA oversight across the business.
To apply, please contact Liam@requireconsultancy.com