Microbiology Manager in Skipton

The QC Microbiology Manager has the responsibility of assuring that microbiological quality control systems and activities, associated training, and environmental monitoring within the Dechra Skipton facility are meeting cGMP regulation and guidelines. In this role you are responsible for providing effective leadership within the microbiological laboratory. You are responsible for the proper functioning of the team and for an efficient and smooth flow of the analyses.

Responsibilities:

• Stay abreast of developments in the field through training, reading of literature, documentation and the like.
• Provide technical expertise to identify and facilitate the update of methodologies and best practices.
• Ensure microbiological best practices are adhered to for all site projects and in particular those which implement new equipment, technology, analytical methods, processes or materials.
• Stimulate safe working and continuous improvement of the quality culture.
• Support continuous improvement program throughout the company.
• Cross‑functional collaboration to ensure the day‑to‑day management of the departmental process, to ensure that common goals are met, plans are established and implemented, to meet product delivery requirements.
• Support the generation of resource plans.
• Lead, coach, train and motivate Microbiologists as well as conduct PDR, development interviews, etc.
• Participate in operational work meetings and internal quality meetings.
• Perform out‑of‑specification investigations, environmental excursion investigations and deviations per company procedures.
• Develop and validate testing methods used in routine analysis of incoming raw materials and finished products.
• Assist in writing validation protocols, project reports, updating laboratory documentation, SOPs, and test methods.
• Provide strategic influence to the site to help ensure good practices are implemented and maintained in the manufacturing areas.
• Provide microbiological expertise during the planning and introduction of new procedures, new products and process improvements.
• Perform quality assessments on the microbiological performance related to utilities, HVAC, bioburden and environmental monitoring in support of batch release by the QP.
• Lead the investigations on microbiology related excursions, and provide support to production, quality control and quality assurance groups during investigations.
• Approve monthly microbiology and environmental monitoring trend reports of production areas and utilities.
• Liaise with the QC microbiologists on the microbiological trending programme and corrective actions.

Qualifications:

• BSc Hons in a Science subject eg. Microbiology or equivalent in scientific field or relevant experience.
• Strong knowledge of USP, EU, and ISO regulations is a must.
• Minimum of 3 years of relevant experience in a pharmaceutical GMP quality control laboratory.
• Knowledge of Microbiological testing such as LAL, Membrane Filtration, bioburden, environmental monitoring, Dispersion, Use of a Microscope, Gram staining, Incubation of samples.
• Knowledge of laboratory equipment to be used.
• Coaching and mentoring.
• Computer literate including word and excel.
• Excellent concise technical writing skills with attention to detail including formatting for clarity.
• Knowledge of environmental, health and safety, and regulatory standards.
• Prior experience with writing protocols, data review, authoring SOPS, Change Controls, out‑of‑specification investigations, and report writing.
• Strong analytical and problem‑solving skills.
• Make sound judgement from data.
• Works independently.

What Dechra can offer you:

• Due to the nature of our business, all successful candidates will be required to complete a basic DBS check (Disclosure and Barring Service check) before employment can commence, and at regular intervals during employment. This check will be paid for by Dechra.
• Average 36‑hour working week (with a day off every other Friday!!)
• Plenty of training and development opportunities.
• 22.5 days annual leave + Bank holidays.
• Option to buy a week's holiday each year.
• Free access to the Headspace App.
• Employee Assistance Programme.
• Free on‑site parking.

Dechra is a global specialist in veterinary pharmaceuticals and related products business. Our expertise is in the development, manufacture, marketing and sales of high quality products exclusively for veterinarians worldwide. We are a global leader in veterinary endocrinology and topical dermatology, have a broad portfolio of analgesia, anaesthetics and products for the treatment of pain, and are also recognised as innovators in other specialisations such as the treatment of equine lameness, nutrition and differentiated generics. We deliver high quality products and services to veterinarians worldwide through our employees and a network of third parties to sustainably improve global animal health and welfare. Everything we do is underpinned by our culture and values. They are important to us and have helped drive the Group's success.