QA/QC Scientific Document Controller
We are looking to recruit someone who will be responsible for the integrity of all documentation that leaves the analytical laboratory. The successful applicant will have a keen eye for detail, has knowledge of scientific writing, has a good understanding of cGMP regulations, is computer literate and is confident working as part of a busy team.
Reporting to the Analytical Services Manager specific duties will include:
• Completing accurate and timely reviews of all analytical data including HPLC, GC, IR, Mass Spec
• Reviewing and assessing validation and analytical instrumentation qualification documentation
• Co-ordination, review and update of analytical SOP’s
• In association with the Analytical Services Manager co-ordinate training within the analytical laboratory and maintenance of the analytical training files.
• Co-ordination, review and update of generic analytical methods in compliance with current Pharmacopoeia’s and regulations
• Fulfilment of Corrective and Preventive Actions (CAPA) requirements and change controls as appropriate
• Identifying Quality System gaps within the Analytical Services Department and developing processes to mitigate them
• Perform internal audits in association with the QA department
SKILLS & EXPERIENCE
• Excellent oral and written communication skills, with the ability to proofread.
• Experience with Scientific and/or Pharmaceutical terms.
• Experience working to GMP and related practices for the manufacture of active pharmaceutical products.
• Strong organisation skills.
• Able to work with the production schedule and plan accordingly.
• Able to adapt to changes in schedule and respond accordingly in order to issue current, effective documentation.
• Excellent interpersonal skills are required as this position requires daily contact with other internal departments.
• Excellent Microsoft Office skills.
• Thorough approach and high attention to detail.
The post will be full time but may be negotiable for an outstanding applicant.
To apply, please send your CV and covering letter to Nathan Lane by email at: Nathan.firstname.lastname@example.org