Quality Control Manager Job in Gillingham SP8 4XT, South West UK
Quality Control Manager
Based: Dorset
Salary: 45-52K Dependant on experience + Bonus + Pension + Life Insurance + Car + Healthcare + Relocation
My client is ranked in the World’s Top 10 Fine Chemical Companies with revenues of $647 million. They are a growing business providing a wide range of products and services for pharmaceutical and biopharmaceutical companies to develop and commercialise small-molecule APIs and biologic drug products.
Having significantly expanded their contract manufacturing services over the past 5 years through major investment and acquisitions, they are looking to recruit a Quality Control Manager to join their successful team.
The Role:
· Coming from a background in fine chemical manufacturing or Active Pharmaceuticals Ingredients The Quality Control Manager will lead the function and a team of QC Analysts and will be responsible for the daily operation of the QC function, including scheduling testing and instrument time, setting priorities, maintaining laboratory standards, housekeeping/organization, personnel management, and cGMP compliance.
· The Job Holder will interact with customers, quality auditors, and regulatory/compliance investigators. Presentation of analytical data and results plus the responsibility for the review and approval or rejection of raw materials and components are a key focus.
· Leading a team of 15 Quality Control Analysts, to provide QC services to multiple locations this role will require the right candidate to liaise with Development, Production and PM, planning, executing and reporting QC work in order to ensure that priorities are met and that optimal usage of resource is achieved.
· This individual will establish KPIs to demonstrate continuous achievement of performance and service levels. It will also take responsibility to review specifications, qualification, validation and procedural documentation in order to maintain compliance and ensure the safe and efficient operation of QC services.
· Knowledge of cGMP compliance as it relates to the Good control laboratory Practice; implements necessary systems, procedures, documentation, and training to maintain cGMP compliance in QC.
· You will assist QC personnel in conducting, documented laboratory out-of-specification (OOS) investigations.
The Requirements:
· BSc in Chemistry or related subject
· Managerial experience in a cGMP/GLP compliant analytical laboratory and experience of method validation/verification
· Previous participation in regulatory (FDA, MHRA) inspections and in the implementation or utilization of LIMS
· Proven supervisory/organisational skills.
· Excellent communication/presentation skills.
· In depth understanding of cGMP requirements for QC activities
· In depth understanding of analytical chemistry and laboratory procedures.
To find out more information please contact Kirsty Fenella Smith at Langton Howarth www.langtonhowarth.co.uk– kirsty@langtonhowarth.com +44(0) 113 243 3499 / +44(0)7969 166 123 Please include a cover letter as to why you feel you are suitable for the role and your salary expectations.
API, Active Pharmaceutical Ingredients, Pharmaceuticals, small-molecule APIs, biologic drug products, Quality control, MHRA, FDA, QA, QC, Regulatory, Health Safety, cGMP, OOS,GCP.