QC Team Lead

SGS is the world’s leading Inspection, Verification, Testing and Certification company, with over 98,000 employees in 2,650 locations around the world, including 24 labs in the pharmaceutical sector. We deliver solutions to a wide range of industry sectors in Ireland.

As part of the services we offer to our customers, we offer Scientific Insourcing. This is with the support and guidance of ISL  technical and operational staff. As applies to all SGS personnel, the focus is to maintain high technical and GMP standards, to ensure the safety of the medicine for the millions of patients who take the products we test.

We currently have an exciting opportunity in Wicklow for a QC Team Leader to supervise the Laboratory release functions of Raw Materials, Intermediates, DPI and API’s (including the stability program) and In Process Control.

Responsibilities:

• Provide Leadership and Support across the QC lab
• Represent the Quality Department at meetings both on site and at a corporate level
• Lead Laboratory investigations and identify deviations from quality standards
• Perform QC method troubleshooting as required across a range of analytical techniques including Chromatography
• Drive and promote Quality System improvements within the laboratories.
• Laboratory Documentation review (including documentation RFT improvement),
• Oversee the Planning and Scheduling of Laboratory Testing activities
• Ensure laboratory equipment well is maintained, and calibrations are carried out at the designated frequencies.
• Approval and Disposition of Raw Materials, IPC, Intermediate, Water and Environmental Monitoring and Stability Samples
• Preparing data packages and reports to facilitate CPV and APR’s
• Always looking for improvement/operational excellence opportunties including Laboratory 5S and Lean Labs program
• Perform method transfers and validation according to requirements.
• Lead Tier 1 meetings.
• Take full ownership of Laboratory Systems as assigned.
• Review and approval of procedures ensuring the accuracy of SOP’s, EOP's, Master Analytical Records; compendial changes; analytical Change Authorization packages; static data on ZLIMS; Safe Work permits etc.
• Ensuring full compliance of Laboratory Systems with current regulatory requirements are consistently adhered to.
• At all times, adopt a safe behaviour by exercising due regard for the health and safety of yourself, colleagues, and clients, in line with the Company’s policies and procedures
• Ensure full compliance with the Company’s Code of Integrity, and act in accordance with SGS Ireland’s Equality & Diversity Policy

• Third Level qualification within science, Pharmacy with a minimum of 5 years experience in the management of a GMP analytical lab.
• Strong experience with analytical instrumentation, automated laboratory systems, validation and current regulatory expectations.

• Integrity, consistency and flexibility
• Professionalism: how you conduct yourself with the client, contractors and colleagues always
• Strong analytical ability and associated problem solving
• Organisational skills and computer literate
• Good time management & attention to detail
• Results and performance driven
• Compliance with SGS policies and procedures
• Participate in team meetings / Team player/ Self directed

Along with an attractive compensation, we offer:

• Healthcare contribution
• Pension
• Performance related bonus
• Continuous learning with the chance to expand and enrich your career with our dedicated training team
• Career development opportunities across SGS
• Long service recognition awards
• Employee referral scheme
• Company Sickness policy
• Employee Assistance Programme (EAP)
• Eye sight test & contributions towards glasses
• Mental Health support
• Cycle to work scheme

SGS is an equal opportunities employer