Senior Quality Assurance Officer Permanent/Full Time South East England Competitive salary and package Do you have Quality Assurance experience?Have you worked within a Pharmaceutical/Medical Device...
Senior Quality Assurance Officer Permanent/Full Time South East England Competitive salary and package Do you have Quality Assurance experience?Have you worked within a Pharmaceutical/Medical Device regulated industry?Do you have GMP manufacturing knowledge or experience?Role:
- To support Quality Assurance in efficient functioning and implementation of all Quality plans at site.
- Creation, Implementation, Monitoring, Review and Continuous Improvement initiatives of cGMPs, Quality Management Systems (QMS) and procedures.
- Support in release of finished product to the market.
- Review of change controls, deviations, Out-of-specifications, complaint handling and response, Corrective Actions and Preventive Actions(CAPA).
- Self-Inspection and Internal Quality Audits on regular intervals of all the departments. Preparation and co-ordination for the audits to be conducted by the Regulatory Authorities.
- cGMP / GDP training including identification of training needs, scheduling training programme, imparting training, evaluation and retraining.
- Vendor evaluation and qualification for Active Pharmaceutical Ingredients (API), excipients and packaging components.
- Review and finalization of Technical and Quality Agreements (TQA) for approval.
- Approval and certification of Product Quality Review (PQR) according to EMEA- FDA- requirements.Requirements:
- Graduate, or equivalent, with experience of cGMP and working within a Quality management system environments.
- Demonstrate knowledge and understanding of current regulatory requirements for manufacture licensed medicinal products. Good understating of GMP and GDP and relevant guidelines/updates.
- Knowledge of EU and UK quality related pharmaceutical regulations.
- Experience with Document Control, Deviations, Change Control and CAPA processes.
- Experienced in technical report writing, maintaining quality systems, review data, and monitor data trends.
- Good interpersonal skills and ability to work well within the organisation.
- If you would like to apply for this position, please use the link provided. Alternatively please email a copy of your CV . For more information regarding this position or any others, please call Bal on 0121 222 5331.
- SRG is the UK's number one recruitment company specialising in the scientific, engineering, clinical, pharmaceutical, food/FMCG, energy & renewables, biotech, chemical and medical device sectors.
- If you have a scientific background and this position is not relevant/suitable for you please feel free to get in touch or visit www.srg.co.uk to view our other vacancies.
- Keywords: QA, Quality Assurance, CAPA's, investigations, batch documentation reviews, GMP, GDP, auditing, pharmaceuticals,
- If you have the skills/experience required and are interested in the role please apply online, if you have any questions please call on 0121 222 5331.
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.