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.
You are kindly asked to send your CV to the e-mail address in the Apply for job button by indicating the position name in subject on the following mail address.
