We are seeking a Lead Microbiologist to work for a pharmaceutical manufacturer in Wiltshire.
We are looking for a self-motivated, energetic individual with a proven track record of working as a Microbiologist within a fast-paced environment. You should have 5 years + experience of working in a quality role such as Sterility Assurance or Microbiology. Thorough knowledge and experience of the principles of sterility assurance, quality system design, development and successful registration of GMP facilities, with excellent communication and organisation skills are essential for this role. To undertake this role, you should have practical manufacturing experience and be able to demonstrate technical knowledge of aseptic manufacturing. You should be able to work independently or as part of a team according to the demands of the job. The successful candidate must have good PQS system knowledge (deviations, CAPAs, change control, complaints handling) and awareness of current best practice and opportunities for improvement. We are looking for someone who is a member or eligible to be a member of Royal Society of Biology.
Duties and Responsibilities:
• To provide daily communication with Production Management and QA Management
• To operate a system for trending all microbiology investigations and deviations and to report out this information on a weekly basis
• To oversee investigations pertaining to sterility assurance and to support the closure of items.
• To oversee CAPAs pertaining to sterility assurance and to support the closure of items.
• To update documents and SOPs as required.
• To input into continuous improvement initiatives.
• To ensure that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management.
• To participate in management reviews of process performance, product quality and of the pharmaceutical quality system.
• To be part of the on call rota