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QC Manager

Hays Specialist Recruitment Limited
Job LocationSlough
EducationNot Mentioned
Salary£50,000 - £60,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

Quality Control Manager - QC - Manufacturing - Generics - GMP An exciting opportunity for an experienced Quality Control Lab Manager to join and head a newly established Quality Control department. The QC Manager will be responsible for managing the Quality Control department, organise and run 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 all matters relating to the lab. Responsibilities:

  • To 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.
  • 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.
  • Create, review and approve of relevant Quality Control SOPs.
  • Ensure all SOPs, methods, protocols, method and equipment validation, method development/ transfer and reports are implemented as required.
  • Strong hands-on experience of testing, analysis and development using instrumentational analysis.
  • Ensure Stability programs operate efficiently and support product shelf life to meet regulatory requirements.
  • Maintain Good documentation practices including generation, review, approval, storage and archival of electronic and paper-based documents.
  • Take an active role in both internal and external audits as an auditee and in post audit action and implementation planning.
  • 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.
  • Carry out/oversee risk assessments and impact assessment for the different situations found in a Quality Control laboratory environment.
  • Be involved with the preparation and execution of cleaning validation activity for production and packaging lines.
  • Prepare and execute process validation activity from a Quality Control laboratory perspective.
  • 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.
    • Requirements:
  • Degree in Chemistry, Pharmaceutical Science, Analytical based subject or similar is essential.
  • Significant experience as QC Manager or 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, FTIR in a cGMP 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.
  • Strong IT skills including MS Office
  • Ability to motivate and support others when working under strict deadlines.
  • Excellent verbal and written communication skills
  • Project management knowledge and experience
  • Intermediate/advanced working knowledge of LIMS or equivalent system
    • If you think you match the skills listed above and are looking for a new challenge in the Biotech industry, then please apply with your CV or call Thomas Nash on +44 (0) for a completely confidential chat about your situation.

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