Major accountabilities:

• Responsible for ensuring that all records generated by the laboratory are in accordance with cGMP standards. The Analyst Release must evaluate the analytical data obtained during the analysis of release and stability, as well as pointing out any records not covered by procedures and can result in future deviation.
• Decision to use the release product and/or stability in the SAP system.
• 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.
• Responsible for actively participating in the investigation of laboratory deviations, with the Productive Area, Coordination and QA Operations.
• Updating procedures related to Analytical Records, Investigations of Analytical Deviations, reviewing and updating OOEs in accordance with the procedure and always managing OOSs in the face of occurrences under analysis.
• Review and approval of analytical tests (analytical release) -Microbiological QC -Perform Microbiological testing of materials and utilities, environmental and personnel monitoring.
• Managing the compliance and suitability of microbiological tests outsourced to third-party laboratories in order to maintain proper regulation of the analyses carried out.
• Ensure compliance with Good Laboratory Practices, with the proper management of internal indicators, conducting investigations, reviewing local procedures and evaluating global procedures, managing third-party laboratories, reviewing documents with regulatory impact.
• 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.
• Evaluate and contribute to improving individual performance that of the bench analysts, to improve and minimize documentation errors. (DRFT).   

Minimum Requirements:

Work Experience:

• A bachelor’s degree related to the pharmaceutical area, Chemical or Biological, titled with a professional license.
• > 8 years experience in Pharma/Manufacturing sector in analytical lab.
• Collaborating across boundaries.
• a GMP environment/equivalent.
• Good knowledge of SAP software.

Skills:

• Continuous Learning, Dealing with Ambiguity, Industry Standards, Quality Control (Qc) Testing, Self-Awareness and Technological Expertise.
• Decision-making insight and solutions.
• In the workplace, the quality of interpersonal relationships is one of the most decisive factors in the success and well-being of employees. Good interpersonal relationships not only foster communication, but also contribute to creating a pleasant and productive environment.
• 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 advanced