Microbiology Group Leader, Winsford, Cheshire.
Who are Advanced Medical Solutions?
AMS is a world-leading independent developer and manufacturer of innovative tissue-healing technology, focused on quality outcomes for patients and value for payers. AMS has a wide range of surgical products including tissue adhesives, sutures, haemostats, internal fixation devices and internal sealants, which it markets under its brands LiquiBand, RESORBA, LiquiBandFix8, LIQUIFIX, Peters Surgical, Ifabond, Vitalitec and Seal-G. AMS also supplies wound care dressings such as silver alginates, alginates, and foams through its ActivHeal brand as well as under white label. Since 2019, the Group has made seven acquisitions: Sealantis, an Israeli developer of innovative internal sealants, Biomatlante, a French developer and manufacturer of surgical biomaterials, Raleigh, a leading UK coater and converter of woundcare and bio-diagnostics materials, AFS Medical, an Austrian specialist surgical business, Connexicon, an Irish tissue adhesives specialist, Syntacoll a German specialist in collagen-based absorbable surgical implants and Peters Surgical a global provider of specialty surgical sutures, mechanical haemostasis and internal cyanoacrylate devices. AMS's products, manufactured in the UK, Germany, France, the Netherlands, Thailand, India, the Czech Republic and Israel, are sold globally via a network of multinational or regional partners and distributors, as well as via AMS's own direct sales forces in the UK, Germany, Austria, France, Poland, Benelux, India, the Czech Republic and Russia. The Group has R&D innovation hubs in the UK, Ireland, Germany, France and Israel. Established in 1991, the Group has more than 1,500 employees. For more information, please see www.admedsol.com
AMS provides equal employment opportunities for all applicants. We highly value and encourage diversity across our workforce meaning that no one will be discriminated against because of their gender, race, age, nationality, disability, or any other protected characteristic as prohibited by law.
Responsibilities
* Manage the day to day running of the Microbiology testing operation.
* Acts as subject matter expert (SME) for Microbiology.
* To ensure microbiological testing of raw materials, finished products, microbiological testing, Environmental monitoring is performed in a timely manner.
* To ensure quality procedures are being adhered to.
* To promote and uphold Quality, cGDP, cGMP and Microbiology requirements within Manufacturing and other departments.
* To provide technical support to Manufacturing and other departments.
What will this role involve?
* Ensure that all laboratory test equipment is calibrated, maintained and fit for purpose before use and traceable to generated tested results.
* To ensure quality control activities are performed in accordance with relevant AMS Health, Safety and Environmental policies and procedures.
* Writing and reviewing risk assessments.
* Progress and implement assigned actions to address non-conformities in a timely manner.
* Write Annual reports for Product families and Environmental Monitoring.
* Write protocol and reports for testing validation and equipment.
* Working closely and supporting the QE’s and the Manufacturing department.
* Approving protocols/reports for other departments.
* Arrange and document external Cleanroom Validation.
* Review external Cleanroom Validation reports and findings.
* Responsible for Quality Documents (Change control, NCs, OOS, CAPA, OnBase updates).
* Writing Environmental Monitoring rationales.
* Managing Environmental Monitoring for external customer.
* Perform laboratory and environmental monitoring testing where required.
* Reading test plates and interpreting results.
* Identification and Enumeration of microorganisms (Gram stain and Biochemical)
* Arranging Quarterly Dose Audits and writing reviews.
* Dealing with Quarterly Dose Audit anomalies.
* Assessing/rationale Break Integrity monitoring.
* Support site audits (customer, notified body) relating to microbiology activities.
* Checking and trending Microbiological data.
* Recognises discrepancies in results, raise laboratory investigations when required.
* Ensuring all testing done is carried out to the Laboratory’s standard operating procedures.
* Ensuring all data generated is managed through the laboratory smoothly and contains all the information necessary to allow a true and accurate interpretation of results. The information must be completed / data entered within deadlines of work completion.
* Other managerial activities are 121s, holidays, sick, appraisals, setting objectives and planning work.
* Attending and arranging meetings across the site.
* Raise CAPEX and purchase requisitions.
What we're looking for?
* HNC or equivalent in scientific discipline or the abilities that are typically acquired through a minimum of 4 years’ experience in medical device or pharmaceutical industries.
* Previous Microbiology Laboratory experience is desired.
* Good organisational skills.
* Ability to operate relevant testing instruments.
* Ability to analysis test results and present a report.
* Problem Solving Skills.
* Computer Literate.
* Ability to prioritise workload.
* Flexibility in work scheduling and business needs.
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