Summary
About the Role
Major accountabilities:
- OOx/Deviation handling.
- CAPA definition -KPI trending -Ensure all activities in compliance with cGxP, incl. data integrity review and approval of analytical data / tests (analytical release) Stability -Stability testing (Projects) – protocol preparation, evaluation, report preparation.
- Review and approval of analytical tests (analytical release) -Microbiological QC -Perform Microbiological testing of materials and utilities, environmental and personnel monitoring.
- Collaborate and act actively on the housekeeping program, maintaining the lab clean, organized, standardized, identified according to 6S methodology;
Key performance indicators:
- The relevant KPIs that are defined in the Quality Control areas apply: e.g. analytical lead times -Timely and GMP-compliant analysis & documentation of the results.
- Error rate: Number of OOS (analysis errors) related to the number of analyzes -No complaints about official inspections.
- Individual performance is assessed using the PMP performance dialog together with the manager.
Minimum Requirements:
Work Experience:
- A bachelor’s degree related to the Pharmaceutical area, Chemical or Biological, titled with a professional license.
- >3 years experience in Pharma/Manufacturing sector in analytical lab.
- Collaborating across boundaries.
- a GMP environment/equivalent.
Skills:
- Continuous Learning, Dealing With Ambiguity, Decision Making Skills, Industry Standards, Quality Control (Qc) Testing, Self Awareness and Technological Expertise.
- Solid knowledge in Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP) and GDocP
- Knowledge in current pharmacopoeias such as USP, EP, BP, JP, etc. local and international requirements.
- Knowledge of local, regional and international regulatory standards, such as ANVISA, ICH, FDA, EMA, ANMAT.
- Extensive experience in physicochemical analysis of finished product.
- Knowledge in quality system, such as change control, deviation investigation, OOS, OOT and OOE in the laboratory.
- Knowledge in data integrity principles (ALCOA+)
- Solid knowledge in chromatographic analytical techniques such as: UV/Vis spectrophotometer, dissolution, HPLC, GC and MS-LS. And software such as Empower.
Languages :
- English intermediate / advanced
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