Chief Quality Assurance Specialist
1 week ago
Job Summary:
We are seeking a highly skilled Microbiologist to join our team. As a QC Specialist I (Microbiology), you will be responsible for establishing and ensuring the testing of drug substance release and stability, including all testing of intermediates in process.
You will work closely with cross-functional teams to ensure compliance with written testing SOPs and local/international regulations. Your key responsibilities will include:
- Oxidation/Deviation Handling: Define CAPA, trend KPIs, and ensure activities comply with cGxP, including data integrity review and approval of analytical data/tests (analytical release).
- Stability: Prepare protocols, evaluate, report on stability studies, prepare stability plans, trends, and evaluations; perform comparative reports for supplier qualification; review and approve analytical tests (analytical release); microbiological QC; perform micro testing of materials and utilities, environmental and personnel monitoring; provide expert support for site qualification and validation activities; maintain and calibrate equipment; support supplier qualification; trending and analysis of KPI/KQI; support sample planning and sampling execution; report technical complaints/adverse events/special case scenarios related to Novartis products within 24 hours; distribute marketing samples (where applicable).
- HSE Guidelines: Comply with HSE guidelines, detect and report potential accidents/risks, propose solutions; participate in HSE risk assessments; preparation and participation in internal HSE audits.
Requirements:
To be successful in this role, you should have:
- Professional Experience: At least 6 years of experience in the pharmaceutical sector or in the manufacture of active substances in analytical laboratories in a GMP environment or equivalent.
- Collaboration Skills: Collaboration across boundaries, functional breadth, efficient inter and intra-departmental communications.
- Technical Skills: MS Office applications and other standard IT applications supporting Quality activities; laboratory equipment; Quality Control (QC) knowledge of TQM and related industry GxP standards and processes; Laboratory Excellence; quality decision-making.
Benefits and Rewards:
We offer a competitive compensation package, excellent benefits, and opportunities for professional growth and development. Join our team and contribute to the success of our organization.
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