An exceptional opportunity for a Microbiology Manager with an established company in Ashford (non-food) where you will have overall responsibility for the Microbiology Lab, managing a team of 5 people and report to the QARA Director.
Your areas of responsibility will not only include management of the microbiology team and their development, but also be the SME for microbiology and sterilisation processing in order to ensure compliance to all applicable regulations.
In addition, ensuring the Microbiology Lab maintains good working practices and procedures in accordance with the principles of cGMP and GLP, whilst at the same time, ensure the lab remains compliant with the requirements of the relevant international standard and method validation status is maintained to support product manufacturing, testing and release.
You will oversee the smooth running of the Microbiology lab and to deliver data to the Quality department in a timely manner to facilitate the disposition of finished products.
In addition to full responsibility for the Microbiology Lab, you actively participate and be accountable for QA sterilisation activities and projects in order to assure, but not limited to QSR, MDSAP, GMP and GLP compliance.
You may also support the global organisation from sterilisation/aseptic SME perspective and either lead or participate in cross functional/business projects.
Experience we are seeking:
Previous experience in managing a cGMP/GLP Laboratory.
Experience of managing people.
Strong experience in sterilisation processes, specifically irradiation and ideally, aseptic processing and controls.
Application of relevant ISO, FDA & EU regulations.
Experience in writing technical reports.
Experience of working within a Medical Device or Pharmaceutical manufacturing facility.
Experience in planning and co-ordinating an ISO classified room validation.
Experience in planning conducting and reporting on investigations of microbial contamination of controlled environments and products.
Internal and external audits, acting as SME, hosting visitors.
Educated to Scientific degree level in Microbiology or have equivalent professional experience and/or qualification.
Ideally one or more of the following professional qualifications or licenses.
Quality Auditor Certification/Affiliation to the Institute of Quality Assurance/Membership of a professional body associated with your scientific degree/ Bachelor’s degree in microbiology of science.
Qualifications – Knowledge, Skills & Accountabilities we are seeking:
Strong knowledge in sterilisation processes (explicitly Filtration, Gamma & E-Beam irradiation
Good knowledge of microbiology analysis (bioburden, water, viable and non-viable etc)
Strong knowledge of QSR (Quality System Regulations), MDSAP, MDD relating to sterilisation.
Strong knowledge in Microbiology concepts (ie. spores, bioburden, aseptic techniques, contamination control etc) including aseptic sampling techniques.
Professional competence & knowledge.
Planning and organising, continuous improvement/teamwork/communication/influencing/business sense.
Sound knowledge of core regulatory requirements and laws is a must.
Working knowledge of IS0:13485:2016 and the MHRA Orange Guide requirements.
Fact based decision making approach using Root Cause Analysis.
Experience with statistical tools such as: Minitab or Excel.
Familiarity and competence in the analysis and presentation of complex data.
Actively participate in:
CAPA Board: KPI & Operational Metrics Review.
Support on Internal & External Audits.
Generating NCR – raw material for non-confirming materials.
Ensuring completeness of Quality investigations and CAPA’s.
Identifying corrective/preventive actions.
Completing reports for CAPA.
Global activities within area of expertise (create global policy, procedures etc).
Local & global continuous improvement activities.
Salary & Benefits:
An extremely competitive salary is available for this position, together with attractive benefits.
If you have the desired experience for this senior opportunity, then please email an up to date CV as soon as possible.