Quality Control Manager
I am helping a rapidly growing Pharmaceutical company, based near Hereford and they are currently seeking a Quality Control Lab Manager to join and head the Quality Control department. The QC Manager will be responsible for managing the Quality Control department, organising and running the day to day operations of a pharmaceutical QC testing laboratory and act as a subject matter expert, able to inform and direct relevant stakeholders on all matters relating to the lab.
- Lead the QC department in carrying out analysis on incoming materials, components and finished products as well as data in support of the onsite manufacturing and QC functions.
- You will be required to manage the day to day workload of our Analysts.
- Be the driving force behind the labs' compliance and integrity of work, ensuring agreed timelines are met.
- Ensure that the QC department operate in a fully current GMP manner and ensure all members of the lab have regular training in GMP practices where necessary.
- Ensure compliance with the approved and filed regulatory dossiers for product testing.
- Responsible for the safety of department members, ensuring that all staff are suitably qualified and trained to undertake the tasks assigned to them in a safe and compliant manner.
- Train, coach and mentor team members in all areas of work in the lab and have sound and extensive knowledge of all processes and procedures so as to provide technical support and advice to all team members when required.
- Partake in the writing, reviewing and approving of SOPs.
- You will need to ensure all SOP's, methods, protocols, method and equipment validation, method development / transfer and reports are implemented as required.
- Need a detailed understanding of the following : Out of specification, Out of trend, A typical results, Investigations, Complaints, CAPA, Deviation management, Change control, Root cause analysis, OOC, Date trending & Driving OOT limit.
- A detailed understanding of Specification and Method of Analysis and shelf life specification is essential.
- Good documentation skills are necessary including generation, review, approval, and storage and archival of electronic and paper-based documents.
- Active involvement in both internal and external audits.
- Able to highlight potential issues quickly to relevant stakeholders in a clear, concise and timely manner, offering solutions when appropriate while seeking best practice approaches for future endeavours
- You will need to carry out / oversee risk assessments and impact assessment for the different situations found in a Quality Control laboratory environment.
- You will be involved with the preparing and then executing of cleaning validation activity for production and packaging lines.
- You will be expected to prepare and execute process validation activity from a Quality Control laboratory perspective.
- You will be expected to act as a subject matter expert for the Quality Control Laboratory and all its functions to all internal and external stakeholders at all levels of seniority.
- Any other task given to you by relevant stakeholder in order for you to be able to perform your role.
- Degree in Chemistry, Pharmaceutical Science, Analytical based subject or similar is necessary
- Proven experience of 5+ years as QC Manager or 5-7 years as Deputy Manager running QC or testing team from within the generic pharmaceutical industry
- Strong hands-on experience of undertaking testing, analysis and development using instrumentational analysis such as: HPLC, GC, UV Dissolution and FTIR in a GMP environment
- Extensive knowledge of GMP, ICH guidelines, BP/EP/USP methods with a strong understanding of QA processes and methodologies.
- Extensive knowledge and direct dealings with the MHRA, FDA and other leading governing bodies.
- Results focused, with a business orientated/commercially astute approach
- You must possess excellent verbal and written communication skills
- Ability to develop the core structure and infrastructure for a new, young and expanding Quality Control team
- Excellent decision making, organisational and planning skills.
This is a full time, permanent position working Monday - Friday 8am - 4:30pm.
We offer a unique opportunity to join a fast growing organisation with progression opportunities. A competitive salary is available depending on qualifications and experience, other perks include health cover and a competitve pension as well as the possibility of company vehicle, phone and laptop.
If you are interested in this opportunity, please call . Please ask for Harvey in the Life Sciences team.