Responsibilities:
• Lead and guide the team in preparing and executing work plans, including testing methods.
• Coordinate with external laboratories for outsourced testing and the collection of results.
• Develop, review, and maintain Standard Operating Procedures (SOPs), protocols, and technical reports.
• Approve test results and ensure proper documentation of findings.
• Oversee Corrective and Preventative Actions (CAPAs) and manage change requests for the team.
• Act as the team representative during regulatory inspections and internal audits.
• Investigate deviations and out-of-specification (OOS) results, providing effective solutions.
• Monitor and trend laboratory data to ensure consistent results and process improvement.
• Supervise the training and qualification programs for team members, including certification and re-qualification.
• Manage the procurement, calibration, and validation of laboratory equipment and instruments.
• Ensure proper calibration, maintenance, and operation of laboratory instruments.
• Oversee inventory management and supply of standard reagents and solutions.
Requirements:
• Education: B.Sc. or M.Sc. in Chemistry – a must
• Proven experience in leading and managing an analytical team for a minimum of 3 years.
Experience: Minimum of 5 years of hands-on QC lab experience in the pharmaceutical industry, with at least 3 years specializing in chemistry testing.
• Work in compliance with GMP standards and laboratory procedures.
• Perform chemical and instrumental testing, including HPLC, GC, Water Content, Spectrophotometry, FTIR, and Raw Material Identification.
• Strong leadership and team management capabilities.
• Excellent planning, organizational, and multitasking skills.
• Ability to work independently, stay self-motivated, and meet tight deadlines.
• Outstanding communication skills, both verbal and written.
• High attention to detail and excellent organizational skills.
• Proficiency in reading and writing English at a high level.