Quality Team Leader

Client of Kalamntina

Responsibilities:

• Lead and coordinate the Quality team, including audits, documentation, and verification activities.
• Ensure compliance with GMP and quality systems, including batch records, deviations, CAPA, and change control.
• Manage and investigate deviations and implement corrective and preventive actions (CAPA).
• Conduct internal audits and prepare the facility for regulatory inspections (e.g., JFDA, EMA, WHO).
• Maintain and control quality documentation (SOPs, reports, records).
• Develop and deliver GMP and quality training for QA staff and new employees.

Qualifications:

• Minimum 5 years of experience in the pharmaceutical industry.
• Proven experience managing and preparing for GMP inspections, including handling regulatory authorities and GCC inspections.
• Strong knowledge of GMP requirements and pharmaceutical quality systems.
• Leadership experience and ability to supervise a team.
• Strong communication skills.