SENIOR QUALITY CONTROL ANALYST (MICROBIOLOGICAL)

Description

Job Summary: Senior Quality Control Analyst to perform microbiological analyses on pharmaceutical products, develop methods, and ensure adherence to Good Laboratory Practices. Key Highlights: 1. Performing microbiological analyses and method validation. 2. Providing analytical support and leading laboratory investigations. 3. Participating in continuous improvement projects. Selection process conducted by GNX GROUP for client **EMS INDÚSTRIA FARMACÊUTICA**, located in **HORTOLÂNDIA SP** — would you be interested in participating? JOB DETAILS Position: **SENIOR QUALITY CONTROL ANALYST** Salary: R$ 7.001,31 Meal Benefit: On-site Transportation: Chartered bus or VT Shift: First shift, 4x1 schedule Working Hours: 6:00 AM to 2:24 PM C Contract Type: Temporary for 9 months, with possibility of permanent hiring **Requirements:** **Education:** Bachelor’s degree completed in Chemistry, Chemical Engineering, Pharmacy, Biology, Biochemistry, Biomedicine, or related fields. Minimum 2 years’ experience in Quality Control. **Experience:** Relevant experience required; Knowledge of microbiological analyses; Proficiency in SAP system; English (Technical level) and Microsoft Office suite proficiency preferred. **Specific Knowledge:** Proficiency in SAP system; English (Technical level) and Microsoft Office suite proficiency preferred. Teamwork skills, strong interpersonal relationships, effective communication, dynamism, and proactivity. Ability to perform assigned tasks independently, without constant supervision. **JOB SUMMARY:** Perform microbiological analytical procedures on intermediates and finished products, raw materials, packaging materials, environmental monitoring, cleaning validation, and water testing, in accordance with established and approved analytical methods and/or national or international compendia. Develop and validate analytical methods for Microbiological Quality Control, as well as prepare validation reports and protocols. Ensure compliance with Good Laboratory Practice regulations. Draft, review, and harmonize procedures, and conduct relevant departmental training. Maintain records ensuring compliance with data integrity and traceability guidelines. Initiate quality deviations. Schedule daily analytical testing. Lead and support other analysts in laboratory investigations (quality deviations, CAPA, OOS, and OOT). Provide analytical support to peers, junior analysts, technicians, and assistants within the department and interfacing departments. Support planning for procurement of reference standards and reagents. Monitor progress of equipment qualification and calibration plans within the department. Participate in continuous improvement projects. Perform sampling of raw materials. Ensure departmental compliance with 5S processes. Draft and participate in Change Control Committees and track approvals. Monitor and participate in projects. Prepare technical lists. Review Control Charts. Comply with Corporate Guidelines. Participate in inter-laboratory method transfer activities. Actively engage in continuous improvement projects, A3, and Kaizen initiatives. Minimum Education Level: Bachelor’s Degree * Meal Benefit: On-site * Transportation: Chartered bus or VT