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Deputy QC Manager

An exciting opportunity for an experienced Deputy Quality Control Manager to join a newly established Quality Control department has become available based in Maidenhead.

The Deputy Quality Control Manager will assist the Quality Control Manager organise the day to day operations of a generic pharmaceutical QC testing laboratory and act as a subject matter expert, able to inform and direct relevant stakeholders on matters relating to the lab.

Responsibilities:

, Lead the QC department in carrying out analysis on incoming materials, components and finished products (including stability and other samples) as well as data in support of the onsite manufacturing and QC functions
, Help manage the day to day workload of Senior Analysts, Analysts, Junior Analyst and Lab Assistant.


, Ensure that the QC department operates in a fully current GMP manner and ensure all members of the lab have regular training in GMP practices where necessary.
, Be 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.
, Write, review and approve SOPs.
, Ensure all SOP's, methods, protocols, method and equipment validation, method development/ transfer and reports are implemented as required.
, Have a detailed understanding of the following:
o Out of specification
o Out of trend
o Atypical results
o Investigations
o Complaints
o CAPA
o Deviation management
o Change control
o Root cause analysis
o OOC
o Date trending
o Driving OOT limit.
, Support product shelf life to meet regulatory requirements.
, 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
, Be involved with the preparing and then executing of cleaning validation activity for production and packaging lines.
, 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.

Required Skills:

, Degree in Chemistry, Pharmaceutical Science, Analytical based subject or similar is necessary
, Proven experience of 5+ years as Deputy QC Manager or 5-7 years as Senior Analyst 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:
o HPLC
o GC
o UV Dissolution
o FTIR in a cGMP environment
, Extensive knowledge of GMP, ICH guidelines, BP/EP/USP methods with a strong understanding of QA processes and methodologies.
, Experience of LIMS or equivalent system is desirable.


, Extensive knowledge and direct dealings with the MHRA, FDA and other leading governing bodies.


, Experience in the setting up of a generic testing lab or similar is desirable but not necessary.



For further information about the role, please send a copy of your CV to tbarratt@keypeople.co.uk or call 01727 817 626


  • Start: asap
  • Rate: £38000 - £45000 per annum
  • Location: Maidenhead, England
  • Type: Permanent
  • Industry: Pharmaceutical
  • Recruiter: Key People
  • Tel: +44 (0)1727 817 626
  • Fax: 01727 844 838
  • Email: to view click here
  • Posted: 2020-06-26 15:05:40 -

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