Quality Laboratories Sr Analyst

We are looking for a professional with experience in the Pharmaceutical Industry, specialized in Quality Control Equipment. The candidate must possess knowledge of calibration and qualification criteria for analytical equipment. Possess skills in writing and reviewing procedures and technical documentation, such as URS, POPs, Audit Trails etc. Participate in investigations or risk analyses that involve equipment or systems from Laboratories (Chemical and Microbiological).

Among the desired competencies, stand out:

• Coordinate and follow up on activities related to Calibration, Qualification, and Maintenance of equipment, together with other areas involved and/or external suppliers, ensuring they are in working condition within established schedules.
• Prepare, review procedures/protocols for new equipment acquired and/or new standards to be followed by Laboratories
• Expertise in investigations involving equipment, deviations, and technical problems;
• Autonomy in training, implementation, and maintenance of good laboratory practices (focus on equipment and systems)

Main Responsibilities

• Ensure that all requirements for Good Laboratory Practices and Manufacturing – from Regulatory Agencies (ANVISA, INVIMA, DIGIMID, COFEPRIS etc.), as well as corporate norms and requirements, are met with focus on equipment, systems, and Data Integrity.
• SME of Laboratory Equipment (Chemical and Microbiological), responsible for compliance with calibrations and qualifications
• Investigate problems or failures in laboratory equipment and qualifications, implement and evaluate changes to procedures or workflows related
• Conduct actions for the acquisition of new laboratory equipment
• Contact and negotiate with suppliers (deadlines and scope), service providers, and other areas involved in the process (Projects, Engineering, Pharmaceutical Technology, Quality etc.)
• Represent the laboratory in meetings or global committees when necessary or focused on equipment or improvements