Website Asset Recruitment
QC CHEMIST (This position is Permanent OR Contract)
To perform the analysis of samples and the review of QC data in a timely manner according to approved analytical procedures. Generate the weekly QC Test schedule to meet requirements of the production and shipping plan. Complete the release of Raw Materials including LIMS disposition and SAP Usage decision. Review of Intermediates with LIMS disposition. Execution of Trackwise workflows, including Change controls, OOS and UE records. Completion of thorough Investigations through RCA (root cause analysis). Creation of procedures and protocols. Review of procedures as required.
• Analysis or the review of QC data as required for the testing and release of the following materials: Raw Materials, In-process intermediate samples, API’s, stability samples, microbiological, environmental and cleaning samples. Ensuring that the analysis or review is performed in accordance with approved analytical procedures and is aligned with the production / shipping plan.
• Compile the weekly QC schedule as required, attending the Visual Management board meetings and liaising with microbiology as required for any QC technologist support for PW and EM during weekly schedule.
• When required complete the QC Approval or Rejection of Raw Materials in accordance with test specifications. Assisting in the release of Intermediates through peer review and LIMS disposition.
• Assist in the training of Technologists in QC practices and procedures and review of technologists training.
• Compiling Metrics to display performance for Quality Control Laboratory.
• Additional responsibilities as assigned such as Equipment contracts, equipment related MSCRs, generation / execution of IPS studies.
Liaison with QA, Manufacturing & Supply Chain:
• Liaise with QA personnel to ensure delivery of QC data in accordance with the production plan.
• Execution of Trackwise workflows for Change control, Unplanned event and OOS records. Completing thorough root cause investigations for OOT/OOS results. Determining appropriate Corrective and Preventative actions.
• Liaise with manufacturing personnel to ensure availability of materials in accordance with the production plan
• Working to service level agreements (agreed cycle times) for material release and identify laboratory efficiencies to support the customer requirements.
• Liaise with warehouse personnel to ensure availability of raw materials in accordance with the production plan.
• Attend meetings for planning of material retests and vendor evaluations
Validation and Change Management:
• Assist in Change Control Activities – Documentation, Process, Equipment, Facility, Computer and Analytical.
• Assist in Validation Activities – Process, Equipment, Facility and Computer
• Completion of SAP PM activities
• Active participation in continuous improvement within the Laboratory, generating and implementing lightbulb ideas and supporting OE initiatives (e.g. 5S).
• Ensure Compliance with site EHS systems and procedures e.g. Permit to work Systems, Incident/Accident Investigation procedures etc.
• Ensure completion of department risk assessments as per department requirements
• Ensure participation in relevant EHS unplanned events and ensure accidents/incidents are investigated in a timely manner as assigned by area supervisor
• Ensure attendance at EHS training modules as defined by the site training calendar
Qualifications, Skills & Experience:
• BSc. In Science
• 5+ years of industry experience working with a variety of analytical techniques in a GMP laboratory.
• Experienced in the review of QC analysis and proficient in computerised systems such as Empower, LIMS and Trackwise.
• Strong knowledge of analytical methods and procedures in the QC laboratory.
• Capable of working under minimal direction
• Demonstrated standard of performance with a track record for delivering results on time and to a high standard.
• Excellent attention to detail, for review of GMP documents and for identification of errors or out of trend results.
• Knowledge of cGMP as it relates to API (Requirements of EP, USP and ICH)