Group Sterility Assurance Associate

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Head of Global Recruitment at Advanced Medical Solutions

Group Sterility Assurance Associate – 12 Month Contract

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.

Acts as subject matter expert (SME) to support all activities related to sterility assurance, providing technical expertise and guidance and support site related activities across the group. To assure necessary compliance requirements are met to applicable national/international standards related to sterilisation methods.

Support across AMS Group to make sure Sterility Assurance is in compliance with the applicable requirements of cGMP, MDSAP applicable regulations and the Medical Device directive (MDR). Ensuring the development and improvement of the quality management system across AMS Group.

What will this role involve?

• Responsible for the representation of Sterility Assurance through all product design and development life cycle phases to ensure product sterility, reliability and cost effectiveness.
• To determine whether sterilisation methods are deemed adequate in accordance with applicable regulations and standards (eg ISO 11135, ISO 11137 & ISO 17665) for AMS product portfolio and expansions to product portfolio.
• Performs reviews of updated standards and provides information for effective gap analysis of validations/procedures at site level.
• Ensures all related QMS processes are kept up to date with latest versions of applicable standards and industry guidance. Transposition of applicable national/international standards into quality system procedures and implement them across AMS sites.
• Create and review documentation associated with the AMS quality system related to sterility assurance, including but not limited to: quality plans, verification/validation protocols, risk assessment documentation and updates to quality system and department procedures.
• Supports activities associated with aspects of the Quality Management System including:
• Status of Non‑Conformances, CAPAs, SCARs, Audit observations.
• Participation in Material Review Board (MRB), where required.
• Participation in compliance meetings (Change Control).
• Customer complaints.
• Internal audits.
• Acts as subject matter expert for Sterility Assurance during external audits (Notified Body, Competent Authority) and supplier audits.
• Attend regular communication meetings with cross‑functional teams to identify the root cause of problems and create remedial plans for short‑term and long‑term resolutions.
• Supports continual improvement projects in accordance with company objectives related to sterilisation requirements.
• Any other duty as assigned, where required.

What we\’re looking for?

• BS or equivalent in scientific discipline or the abilities that are typically acquired through a minimum of 2+ years’ experience in medical device or pharmaceutical industries.
• Experience of at least one of the major sterilisation methods i.e. Gamma/EO and application of the applicable ISO standard, or microbiology experience within medical devices.
• Knowledge of the Medical Device regulation.
• Knowledge of cGMP/cGLP.
• Lead Auditor trained to ISO 13485 is preferred but not essential.
• Proficient in Microsoft Office (Word, PowerPoint, Excel).
• Ability to independently plan, execute, and/or problem solve moderate to complex situations.
• Ability to exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
• Ability to manage multiple projects.
• Good written and oral communication skills are required, for example to ensure succinct report generation, effective communication with staff, peer groups, etc. across organisation.

Seniority level

Associate

Employment type

Contract

Job function

Science

Industries

Pharmaceutical Manufacturing

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