J3563CheshirePharmaceutical Permanent£25,000 to £35,000 per annumFull Time17/03/2017Quality Assurance – Compliance
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KEY DUTIES AND RESPONSIBILITIES:
Do you have a scientific background with a good working knowledge of pharmaceutical quality management systems and documentation?
Are looking to further your career within a highly regarded pharmaceutical contract testing facility? Our Client is an independent contract analytical laboratory based on a stunning Business Park servicing the pharmaceutical and healthcare industries. The client are an approved GMP contract laboratory regularly inspected by both the MHRA and FDA.
A unique opportunity to join the Quality team has arisen and we are looking for the successful candidates to be a key figure in helping deliver further success to our clients.
In line with expansion our client are seeking to recruit a hardworking, highly motivated and professional individual with an eye for detail, capable of working within a fast-moving quality laboratory environment.
You will be responsible for supporting quality, laboratory and stability operations across all functions; Pharma Services and Nicotine Containing Products (NCP).
The Quality and Compliance Supervisor is principally responsible for supporting quality and laboratory operations. This is carried out by aiding the management of the day-to-day quality and compliance functions of the business to provide commercial analytical laboratory services for the pharmaceutical and chemical industries.
- To support quality activities within compliance with GMP regulations. - To perform quality/technical support to the operational teams using sound hypothesis and investigational judgment for the completion of out of specification, out of trend, non-conformance and deviation records. - To perform quality/technical documentation review and approval of product and technique based analytical test methods following technical test method transfer. - To perform quality/technical review and approval of test method development, test method assessment and test method validation protocols and reports in accordance with ICH Guidance. - To provide support with business activities relating to the effective validation and qualification of equipment and computerised systems in accordance with regulatory requirements and data integrity. - To support routine laboratory operations in delivering timely, accurate Quality Assurance results under strict cGMP regulations using LIMS. - To review and approve the investigations into product non-conformance in support of the QC teams and ensure all incidents are properly investigated and documented in a timely manner. - To maintain Key Performance Indicators (KPI) for monitoring, managing, and improving the performance of the Quality Assurance Department. - To plan and execute quality projects to support continuous improvement activities.
To be successful in your application to this exciting opportunity as the Quality and Compliance Supervisor we are looking to identify the following on your profile and past history:
1. Relevant degree in a Chemistry or Analytical Chemistry related subject
2. Proven industry experience in commercial laboratory with working knowledge of various laboratory techniques such as; dissolution, titration, moisture analysis, related substances testing, HPLC, UV-Vis and FTIR spectroscopy.
3. A working knowledge and practical experience of reviews and approval of technical documents; protocols, reports, technical summaries including the interpretation of analytical data (such as chromatograms and spectra) and conclusions.
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer that is happy to welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors and is made up of a collaboration of scientists supporting science. We look forward to helping you with your next career moves.