Quality Control Manager

Qualifications:

• Bachelor’s degree or higher in Chemistry, Chemical Engineering, or Pharmacy.
• At least 10 years of experience in the field, including a minimum of 5 years in managerial positions within Quality Control or R&D laboratories in the pharmaceutical industry.
• Advanced proficiency in English.
• Strong analytical thinking skills; team-oriented, well-organized, responsible, and possessing strong interpersonal skills.
• Experienced in managing large teams.
• Knowledgeable in current GMP practices and data integrity/security requirements.
• Advanced knowledge of chromatographic techniques, spectrophotometric techniques, and other fundamental analytical methods.
• Knowledge and experience in raw material and finished product chemical controls.
• Able to adapt to flexible working hours.

Job Description:

• Ensure that chemical analyses of raw materials, intermediates, and finished products; in-process controls; primary–secondary–tertiary packaging material inspections; and physical controls (packaging IPC, finished product and bulk AQL inspections) are performed and reported in accordance with approved methods, company procedures, and current GMP rules and guidelines.
• Monitor the updates of reference documents related to the department (e.g., pharmacopoeias, standards such as ISO, ICH, TSE, etc.) and initiate change control forms (DTF) when necessary to adapt local and international guideline/standard updates into the system.
• Track department-related changes, deviations, internal and external audit actions, DOFIs, and OoS/OoT cases; ensure they are completed accurately and within the required timelines.
• Identify the department’s needs for materials, equipment, physical modifications, investments, training, and staffing; prepare investment budgets; and create and monitor the consumables budget in line with departmental and company objectives.
• Prepare chemical analysis methods used for quality control based on customer requirements, current practices, and necessary changes; manage their transfer to QC laboratories; perform applicability checks and verifications; and ensure that methods remain up to date.
• Organize and oversee calibration and qualification activities of instruments used in quality control analyses to ensure timely completion in accordance with current GMP expectations and company procedures.
• Ensure that QC analyses, related documentation, and raw data are completed fully and on time, following current data integrity practices, local and international standards, GMP guidelines, and company procedures—without delaying production or shipment schedules.
• Ensure onboarding and continuous training of assigned personnel; support the acquisition and implementation of up-to-date technical knowledge; manage team productivity, performance, and motivation; and report on employee development and performance evaluations.
• Represent the department during internal and external audits, as well as local and international authority inspections.
• Participate in internal audits and domestic/international supplier audits when required.