Aseptic Officer (Sterile Operational Quality Leader) - Travel
My client is a global CMO working in a variety of different countries. This opportunity gives you a global outlook on a quality career. not only does it allow you to explore new cultures but it also allows you to explore new area of the pharmaceutical industry. this role allows you to work on a variety of different products for their blue chip clients.
This role will be a first line Quality operational role to actively manage the quality of sterile products within the production environment. The candidate will report directly to production within the BU but will also integrate their work with QA operations to ensure that Quality is built in to Aseptic and sterile products produced and released by the BU to the market.
The role will report to the head of production on the BU site.
Relevant degree e.g. microbiology (preferred), chemistry, biology, pharmacy
Significant experience in quality management in a pharmaceutical or similar environment
Experience of Sterile/Aseptic operations
Experience within both primary and secondary pharmaceutical manufacture (including sterile manufacture); Secondary Manufacture is required
The purpose of the Sterile Operational Quality Leader (SOQL) role is to manage/lead Quality operational aspects of all Aseptic filling and sterilization processes in a compliant, lean and effective way.
The Role exists to deliver effective and efficient support and leadership for sterile products to the production department in the BU. The purpose of the Sterile Operational Quality Leader (SOQL) role is to manage/lead Quality operational aspects of sterile & Aseptic processes in a compliant, lean and effective way.
Key aspects of the role include oversight of;
- all activities which have the potential to impact upon the microbiological integrity and sterility assurance of sterile and Aseptic processes, plant and facility.
- all change control
- all deviation management
- batch release
- raw material management
- routine re-qualification of equipment, systems and processes
- Internal & External audit support as an SME
- Aseptic and Sterile-related customer interactions
- Sample management
- Analytical method
- Intra and inter departmental and corporate relationships with other sterile sites through the SPCI
- Quality operational oversight of all sterile, environmental monitoring and water sampling activities on site.
The SOQL role is:
- Leadership: To be a role model and coach for management, leadership of aseptic practices and Sterile product production including relevant GMP compliance matters
- Leadership: To provide hands on leadership to production on all matters of Aseptic and sterile products manufacturing
- Management: To contribute to the management of the production function, through active and supportive membership of the Leadership Team.
- Management: To manage daily operational activities with a positive and proactive prevention first culture
- Management: To ensure customer & regulatory requirements are understood and documented and that customer complaints relating to sterile products are progressed in a timely manner.
This position is based in either spain, italy, greece, the netherlands or france. This is a perfect opportunity for someone who wants a change in 2016. ENGLISH LANGUAGE IS A MUST.
KEY WORDS: QMS, Quality Management System, Quality Assurance, Risk Management, Compliance, CAPA, sterile, aseptic, Medical Devices, German, ISO 13485, ISO 9001, GMP, Medical Device jobs, Ireland, Nonstop recruitment, Manufacturing, Engineering, process optimisation, Auditor, Audits, Auditing, good manufacturing practice
If this role is of interest to you then do not hesitate to get in contact today as my client is looking to select suitable CV's in the next week. Please send your CV in MS Word format (I am unable to accept PDF copies!) to me directly, Ruby Wallace, at firstname.lastname@example.org, or by calling me on 02079402105 for a discussion in confidence.
NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.
What I offer: As a specialist head hunter within quality assurance for the healthcare industry I can offer: market knowledge and a personal service, therefore not just finding you suitable roles but in addition to this offering accurate and honest advice about salaries, work conditions and department reputations for positions across Switzerland and the EU.