Position Summary The Senior Quality Control Scientist will oversee the laboratory-based QC team personnel in performing QC analysis in clinical and stability studies in compliance with MedPharm SOPs and GxP guidelines including EudraLex Vol 4 and 2003/94/EC.
They will author, review and approve QC / GxP documentation and provide training and guidance to other members of the QC team and play an active role in identifying and implementing process improvements.
Essential Functions To oversee the laboratory-based QC scientists and the QC laboratory To liaise with the Associate Director of Quality Control and QC scientists and help provide a schedule for the QC workload to ensure timelines are adhered to To liaise with Production, QA and Project and Study Managers on existing and upcoming client projects To perform review of analysis of raw materials, clinical material and stability samples in compliance with MedPharm SOPs and GxP guidelines including EudraLex Vol 4, 2001/83/EC, 2003/94/EC and United Kingdom SI 1999 No 3106 and applicable monographs To ensure and promote data integrity in the QC team To raise, execute and approve Quality Records including laboratory investigations (OOS/OOT/Atypical), deviations, CAPAs and Change Controls in a timely manner To author QC / GxP documentation according to MedPharm SOPs and GxP guidelines (includes but is not limited to specifications, certificate of analysis, protocols, methods, SOPs) To coordinate, and be involved in, the upkeep of the QC laboratories and equipment in alignment with the MedPharm validation policy and ensure the QC function is in a state of inspection readiness To partake in internal, client and regulatory inspections To provide training and technical input to other members of QC where competent and considered a subject matter expert To actively adhere to the personal training plan and continue personal professional development with role To participate in probationary and annual reviews, and goals and objectives setting, of QC scientists To adhere to MedPharm SOPs at all times To adhere to MedPharm Health & Safety policy and COSHH regulations at all times and ensure the safety of others in any procedures or tasks performed To ensure that all QC documentation, computer data and records are completed and stored appropriately in accordance with MedPharm SOPs and data integrity best practices To assist the Senior Director of Pharmaceutical Analysis and Operations and the Associate Director of Quality Control and other managers in gathering metrics and identifying and implementing process improvements in accordance with ICH Q10 and EudraLex Vol 4 To participate in internal meetings, client meetings and telephone conferences on behalf of the Quality Control department To liaise, manage and collaborate with suppliers and contractors when required Supervisory responsibilities : Quality Control Specialist 1 Key Relationships (examples: Depts or Individual positions that this position will be working closely with): Associate Director of Quality Control Quality Control Team Members Senior Director of Pharmaceutical Analysis and Operations Production Quality Assurance Project and Study Managers Analytical Team Leaders and Personnel External Contractors and Suppliers Current and Potential Clients Education and Experience BSc in a relevant scientific discipline (experience may be used in lieu of education) Minimum of 3 years of working in a GMP / QC environment Working knowledge of HPLC and physical characterisation analysis techniques Previous experience of using Empower CDS desirable Knowledge, Skills, and Abilities Experience of working in a regulated (GMP) environment Previous experience in pharmaceutical industry CMO, CRO or big pharma Knowledge of Quality Control processes in the pharmaceutical industry Demonstrated ability in data review in line with regulatory requirements, data integrity guidelines and the principles of ALCOA and exhibit an analytical eye for detail.
Previous experience of regulatory, client and internal inspections Must have a meticulous approach to work and be highly organised and extremely driven.
Previous experience of authoring and reviewing Quality Records (Deviations, CAPAs and Change Controls) Ability to multitask, manage time efficiently and be able to prioritise Good communication skills both written and oral Ability to work independently and in a team environment Must have a proactive and self-starting approach, consistently taking initiative Competency in the use of Microsoft Office programs (Word, Excel and PowerPoint) Other Duties You may be asked to take on any other responsibilities or tasks that are within your skills and abilities whenever reasonably asked.
Limitations and Disclaimer The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required for the position.
The Company is committed to making reasonable adjustments to the workplace to ensure the role is accessible to all candidates, including those with disabilities.
To perform the job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently.
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