GMP Compliance Specialist

We are looking for “GMP Compliance Specialist" (only local candidates will be considered) with the requirements below:

Key Responsibilities:

• Ensure that manufacturing and laboratory activities comply with GMP requirements.
• Review manufacturing batch records, production protocols, and product formulas.
• Support the planning and coordination of regulatory authority and customer audits.
• Participate in internal and supplier audits, prepare reports, and follow up on corrective actions.
• Manage risk assessment processes for manufacturing and quality systems, and periodically monitor risk assessments.
• Monitor and maintain Quality Assurance documentation processes.
• Coordinate and manage Quality Assurance training activities.
• Support activities related to Deviation Management, Corrective and Preventive Actions (CAPA), Change Control, and Customer Complaints.
• Prepare and report Quality Metrics.

Qualifications & Requirements:

• Bachelor's degree in Pharmacy, Chemistry, Chemical Engineering, Biology, or a related field.
• Minimum of 2 years of experience in the Quality Assurance department within the pharmaceutical industry.
• Advanced proficiency in English.
• Strong knowledge of current Good Manufacturing Practices (GMP) and GMP compliance processes.
• Good understanding of manufacturing and quality control processes.
• Familiarity with SAP is preferred.
• Proficiency in current Microsoft Office applications and other computer software.
• Strong analytical thinking, effective communication skills, and the ability to work collaboratively in a team environment.