Job description

QC Team Leader

About Your New Employer

My client is a leader in the pharmaceutical and healthcare industry. They are committed to making a significant impact in the world by changing lives for the better.

About Your New Job

• You must provide development and leadership to a core team of QC Analysts.
• You must schedule, co-ordinate & supervise all analytical activities within the QC Laboratory ensuring all activities are carried out in a timely manner to meet company objectives and relevant key performance indicators.
• You must co-ordinate QC sampling routines such as covering APIs, utilities, final product and method transfers with timely production of relevant QC Documentation including protocols, reports, Analytical data sheets, SOPs, change controls, deviations and IRF’s.
• You must review and approve non-chromatographic and chromatographic data. Review and approve filled product, raw material and stability analytical data sheets in a timely manner to meet company objectives.
• You must support QA personnel in close out of QC batch release and stability program issues.
• You must co-ordinate and supervise laboratory investigations to ensure they are captured, documented and actioned.
• You must compile of technical reports to support laboratory investigations, qualifications, and trend evaluations.
• You must lead the chromatography and wet chemistry training of QC analysts
• You must manage QC SOPs, change controls, deviations, CAPAs and lab Ensure cGMP compliance is maintained in the QC laboratory at all times.
• You must co-ordinate instrument calibrations & maintenance and qualification to specified schedules.
• You must support continuous improvement projects such as 6S and lean processes for the laboratory.
• You must participate in internal audit and laboratory walkthrough programs and represent the QC laboratory in third party inspections as required and provide input to regulatory files in support of new product submissions and approvals.

What Skills You Need

• You must have a minimum of a bachelor's degree (or equivalent) in a Science related discipline (Chemistry, Biochemistry or Analytical science) and 7 years of relevant industrial experience.
• You must have previous HPLC/GC/peptide analysis experience in method validation / transfer (preferably with Empower software).
• You must possess strong working knowledge of chemistry biochemistry (wet chemistry & chromatographic and peptide analysis) techniques.
• You must have knowledge of Empower, LIMS and other lab software systems.
• You must have people management experience.
• You must possess strong analytical skills with excellent attention to detail, and communication skills both verbal & written with good time management skills.

What’s on Offer

• Meaningful career progression
• Excellent working-life balance
• Flexitime
• Healthcare
• Pension scheme

What’s Next

Apply now by clicking the “Apply Now" button or call me, Dominic King on +353 91 455309 or email: dking@sigmar.ie

Or if the job isn’t quite right but you are looking for something similar, please get in touch. We also have multiple Temp, FTC and Contract jobs available.

Why Apply Through Sigmar?

• We’ll help manage your job hunt, strengthen your interview skills and tidy up your CV
• We’ll provide you with an overview of the jobs market within your industry and help you tailor your jobs search
• Gain access to exclusive roles that are not advertised elsewhere