We are seeking a number of QC & Stability Compliance Specialists to support QC and Stability by ensuring all compliance related issues within the department are fully supported and to communicate compliance updates as required. The role will report directly to the Supply Chain Manager.
- Progression of QC & Stability Investigations in conjunction with Team Leads, Manager and Quality Assurance.
- Review the trends from QC & Stability deviations and propose effective preventative actions / training requirements.
- Generate reports for the QC & Stability department as required e.g. out of specifications trends, Water Trend Analysis.
- Pharmacopeia reviews - perform as per schedule and ensure required updates are implemented and communicated to all relevant personnel (internal and external).
- Liaise with QA Compliance Department for APR's / PQR's and assist in the compilation of these when required.
- Assist in the progression of CACI's and long term actions.
- Review training metrics for compliance. Assist in new Learning Management System implementation and maintenance from laboratory updates when required.
- Progression / monitoring of change control actions required for laboratory to complete or any impacting the laboratory.
- Assist with Regulatory requests e.g. updating of documents following deficiency responses.
- Assist with introduction of reduced testing of raw materials where required.
- To support all other on-going laboratory functions for compliance requirements.
- To ensure that all work carried out is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.
- To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement.
- Check own work and that of others for accuracy.
- To assist in the preparation for internal / customer/ regulatory inspections.
- Draft, review or revise documentation within the documentation management system
- Implement safety requirements as per site documentation including SOPs, Safety Statement and COPs
Minimum Qualifications & Experience
- A relevant qualification in Analytical Chemistry, Pharmaceutical science or related discipline.
- At least five years' experience working in a regulated environment is preferable with a proven track history of report writing and in the progression of deviations, CACI's etc.
Skills, Competencies, Teamwork & Collaboration
- Excellent Communication skills, both verbal & written.
- Analysis - secure relevant information and identify key issues and relationships from a base of information; relate and compare data from different sources, identifying cause-effect relationships.
- Strong analytical ability and demonstrable problem solving abilities
- Knowledge & proficiency of Microsoft products including, Excel, Word & Powerpoint.
- Ability to multitask & work under pressure, coping with more than one conflicting task at once.
- Broad understanding of regulatory requirements for submission of dossiers in EU, USA, Japan and other jurisdictions
- Working effectively with team or those outside the formal line of authority to accomplish organisational goals; taking actions that respect the needs and contributions of others, subordinating own objectives to the objectives of the organisation.
- Making efforts to listen and understand the customer (both internal and external); anticipating and providing solutions to customer's needs; giving high priority to customer satisfaction.
For further information on this role please contact James on 016455250 or firstname.lastname@example.org