QC Lead Chemistry Ma....
QC Lead Chemistry Material Handling
Posted on :
08-03-2024
Employer Active
1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
08-03-2024
Job Description
Req ID : 2605698
QUALIFICATIONS NEEDED:
• Degree or diploma in Chemistry / Analytical Chemistry / Biochemistry /Biotechnology or equivalent.
NECESSARY EXPERIENCE AND INDUSTRY KNOWLEDGE:
• At least 8 years of experience in the vaccine/pharmaceutical/biotech manufacturing industry.
• At least 5 years of experience at the management level.
• Experience in quality and regulatory compliance within a cGMP facility.
• Technical knowledge of Good Laboratory Practices and Chemistry methods.
KEY DUTIES & AND RESPONSIBILITIES OF THE ROLE:
Core Technical Delivery:
• Drive continuous improvement plans and priorities through the implementation of appropriate tools or methodologies to proactively manage risk reduce wastage and to improve quality on Chemistry and site.
• Manage approval of laboratory raw data and investigation of outofspecification results where applicable (Chemistry and Material Handling)
. • Manage the compilation of analytical method and cleaning validation/ verification protocols and reports.
• Manage the compilation review approval of user requirement specification and/or user briefs qualification documents CAPEX approval Risk Assessment Change Management and implementation of new and updated equipment and software.
• Manage the selection and procurement of analytical test equipment and participation in equipment qualification (Chemistry).
• Manage the execution of project activities according to agreed project timelines. • Manage Sampling and testing and release of starting materials (e.g. raw materials production devices and packaging materials) used in production processes.
• Manage Chemistry testing of intermediate and finished product testing as per product specifications.
• Manage visual inspection activities of inprocess and final products as per the required SOPs and product specifications related to vaccines and packaging activities.
• Manage the review of analytical method validation/ verification protocols and reports and coordination with a focus on Chemistry testing.
• Maintaining that Stability Program including compiling stability protocols and reports related to Chemistry testing
. • Participation in project teams as a QC representative.
• Ensure that Chemistry testing is performed according to the Company’s Stability Program. Assist with the compilation of stability protocols and reports.
• Manage the transfer of analytical methods from technology transfer partners to the company and their implementation in the laboratory with a focus on chemistry testing.
• Manage the writing and updating of material and product test methods and standard operating procedures
• Manage Data Integrity in the QC Laboratory with reference to Chemistry along with new and upcoming technologies (e.g. LIMS new hardware and software programs new technologies) when available.
• Liaise with suppliers on technical issues where applicable.
• Manage training coaching and competency assessment of Chemistry staff to approve procedures and protocols.
• Participate in quality audits and close any gaps in findings.
• Ensure that OOS and OOT investigations are initiated and completed to the correct standard within the required due dates.
• Participate in inspections investigations risk management and quality review exercises.
• Execute project activities according to agreed project timelines and within cGMP requirements
• Manage the Operational Expenses (OPEX) Capital expenditure (CAPEX) cost control and budgeting for the Chemistry department in conjunction with the QC Manager.
• Participate in significant Chemistry investigations that can impact product Quality and patient safety.
• Lead significant chemistry Risk assessments following cGMP guidelines (e.g. ICH Q9 ICG Q10 etc).
• Lead engagement with external thirdparty stakeholders regarding Chemistry areas.
• Provide technical guidance to QC teams and other stakeholders within the business from a Chemistry perspective.
• Manage the review and approval of significant documentation within the Chemistry team as defined within local procedures.
Employment Type
Full Time
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