QA Validation and Change Control Specialist

The QA Validation and Change Control Specialist will be responsible for participating in, reviewing, and approving various validation processes, including equipment, process, cleaning, analytical methods, infrastructure, systems, clean rooms, shipping, computerized systems, and control systems. The role includes setting quality policies within the team's responsibility, managing change controls, conducting risk assessments, providing ongoing support for projects, engineering, and maintenance, and participating in audits by regulatory bodies and customers. Key Responsibilities: Drafting protocols and reports for process validation and cleaning validation. Conducting risk assessments. Reviewing and approving validations (equipment, systems, clean rooms, infrastructure, analytical methods). Managing change controls and quality records (deviations, CAPA). Writing and approving standard operating procedures (SOPs). Supporting quality assurance tasks: internal audits, supplier audits, and participation in audits by regulatory bodies and customers. Leading quality improvement processes. Deep familiarity with relevant regulatory standards. Previous experience in writing, reviewing, and approving validations (equipment, systems, process, cleaning, infrastructure) in the pharmaceutical industry. Experience in drafting protocols and reports. Strong engineering orientation. High proficiency in English, with excellent verbal and written communication skills. Education: Bachelor's degree or higher in Biotechnology Engineering, Chemical Engineering, Pharmaceutical Engineering, Biomedical Engineering, Biochemistry, Life Sciences, Chemistry, Biotechnology, or Pharmacy. This position is open to all qualified candidates regardless of gender.