Quality Specialist

Qualifications:

Experience should be in the pharmaceutical/chemical industry or government drug-regulatory agency with a working knowledge of cGMP regulations. Effective communications (oral/written) and interpersonal skills are necessary.

Responsibilities:

The team is the Global Development Quality (GDQ) team which is a group within MRL and is involved in supporting the global GMP Quality Assurance activities for the IMP Licence at the site.

Using this site licence we release all Clinical lots to Clinics in the EU and Rest of World.

We currently have a team of Quality Specialists, QPs and myself heading up the team.

We work closely with similar teams in London, Switzerland and US in these activities to maintain the Clinical Supply Chain.

The role is a day role and involves the following responsibilities and activities:

* Complete auditing/ review of batch documentation to ensure compliance to SOPs, GMPs and applicable regulations

* Review and approve production and analytical documentation accompanying the release of drug substance, drug product and packaged finished goods to ensure conformance to appropriate SOPs, GMP and regulatory requirements, including supporting QP certification.

* Actively communicate and collaborate with functional areas to develop a strong working relationship and understanding of roles and responsibilities.

* Utilise this network to help resolve comments and issues that arise during audit and review.

* Manage product recalls and stock recoveries as appropriate.

* Identify compliance gaps and make recommendations for continuous improvement

* Create and maintain assigned SOPs.

* Perform and review complaints and deviation investigations, change controls and CAPA's.

* Assist in the induction process for new starters and training of other staff.

* Generally follows standard procedures and consults with manager/supervisor to ensure resolution of exceptions.

* Compile data for reports and presentations, provide data interpretation, draw conclusions.

* Carry out all assignments to the standards of compliance, efficiency, innovation, accuracy and safety in accordance with Company and regulatory requirements.

* Keeps abreast of cGMP requirements as described in applicable worldwide regulations.

* Represents department on cross functional teams. * Assist in the generation, review and approval of Technical & Quality Agreements.

* Additional activities as assigned by the manager/supervisor Skills Required

* The Specialist is required to possess a degree in a Quality, Science or Engineering discipline and potentially a higher degree and/or significant industrial experience. They must possess > years industry experience.