About Custom Pharma Services (CPS)
CPS is a full-service Clinical to Commercial CDMO and holds various licences to operate a range of services which includes MIA, Specials, IMP, WDL, and Vet D.
CPS is an independent OSD specialist pharma contract services provider. CPS produces a range of formulation technologies including modified release and potent products such as hormones at low dose.
New development and commercial manufacturing facilities for high potency contained processing have recently been acquired at a site adjacent to our existing Brighton, Moulsecoomb packaging and QC facilities.
About the role
In summary this will include :
Day to day management of FP and RM Team Managers, Analysts and Technicians.
Ensure use and management of Controlled Drugs to Home Office requirements.
Tracking of agreed KPI’s, preparation of reports on agreed performance criteria for the QC department, along with the preparation of Ad Hoc reports as required to senior management and across site.
Facing client audits on behalf of Custom and ensuring the area is always audit ready.
Adherence of testing schedules as planned in order to meet demand.
Effective communication with other departments on progress of QC activities.
Ensuring the QC laboratory is fully stocked and equipped to perform the necessary activities.
Lead Out of Specification (OOS) and Out of Expectation (OOE) investigations by applying initiative and problem-solving skills.
Manage the activities of contract laboratories to Custom Pharma Services.
Review and authorisation of finished product, raw material and packing material specifications.
Review, manage and optimise the performance of staff and resources.
Development of staff to meet Company and individual needs and in line with the Company’s policy of being an Investor in People’.
Ensure maximum co-operation and communication between Quality Control and other departments, to ensure optimum performance levels consistent with the achievement of business plans.
Qualifications, experience, knowledge & skills required :
Degree in a relevant scientific discipline
Minimum of 3 year’s experience in a similar management role within a pharmaceutical QC Laboratory.
Practical experience of Good Manufacturing Practice (GMP) and Good Clinical Laboratory Practise (GCLP) and its application.
Practical experience of Health & Safety in a laboratory surrounding and experience with COSHH and performing task-based risk assessments.
Extensive experience with laboratory out of specification (OOE) investigations.
Ability to direct complex scientific investigations and present data in easily understood reports.
Demonstrable leadership and communication skills.
Excellent planning, organisational and prioritisation skills.
An interest in and an ability to train staff.
Ability to identify skill gaps within team and formulate a training and development plan
Application and knowledge of risk management strategies.
Must be literate and numerate to a high level, including application of statistical methods
Strong documentation skills.
Ability to follow written procedures with accuracy and efficiency.
Excellent attention to detail.
Well-developed interpersonal skills.
Ability to develop and maintain effective working relationships with colleagues and other company personnel across a diverse workforce.
Ability to work in a team which has both internal and external business reporting relationships.
Excellent problem-solving skills.
Benefits include : Holiday; pension; life assurance; health plan; subsidised gym and annual profit related company and individual bonus payment based on successful performance.
Relocation Assistance will be taken into consideration for candidates who are not based within commuting distance of Brighton & Hove