Responsibilities

• Create, draft, and revise Standard Operating Procedures (SOPs) in compliance with Good Manufacturing Practice (GMP) requirements.
• Participate in activities arising from Corrective and Preventive Actions (CAPA).
• Participate in the preparation of the Annual Product Quality Review (APQR).
• Prepare validation protocols.
• Review manufacturing batch records and logbooks related to daily operations.
• Review and prepare qualification documentation and ensure appropriate labeling.
• Participate in deviation investigations.
• Implement and manage change control activities.
• Maintain records of SOPs and their periodic review.
• Maintain records of regular and extraordinary GMP training in accordance with the training plan.
• Maintain records and archive documentation related to manufacturing processes and daily operations in compliance with GMP requirements.
• Participate in monitoring the timely distribution of Certificates for raw materials, intermediate products, and finished products.
• Monitor the issuance and distribution process of labels intended for manufacturing operations in accordance with GMP requirements.
• Participate in performing risk assessments for production-related processes.
• Prepare trend analyses of results.
• Participate in the management of the raw material control system.
• Effectively contribute to the implementation of accurate root cause analyses to identify the underlying causes of issues and support continuous improvement.
• Perform other duties related to Quality Assurance programs and procedures, in accordance with the employee's qualifications, skills, and competencies.
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Qualifications

• Minimum of 2 years of experience in a Quality Assurance department.
• Bachelor's degree in one of the following fields: Pharmacy, Chemistry, or Biology.
• Strong ability to maintain a Quality Assurance system, including batch record review, document control, and quality-related investigations.
• Excellent knowledge of Microsoft Office.
• Excellent technical writing skills (SOPs, Annual Product Quality Reviews, investigation reports, etc.).
• Ability to work independently with strong attention to detail.
• Excellent written and spoken English language skills.
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What we offer:

By investing in new development capabilities, state-of-the-art manufacturing facility, and partnerships we have the opportunity to shape the future of SINCERITAS and give more patients access to affordable, high-quality medicines - sustainably. Our dynamism and entrepreneurial spirit are driven by an open, collaborative culture, supported by our talented and ambitious colleagues who, in return for the use of their skills, experience an agile and collegial environment with impactful, flexible careers in which diversity is welcome and personal development is encouraged!

In addition to a basic salary in line with market, we offer:

1. Organized transport from Skopje to Rosoman

2. Provided meal for all the employees

3. Collective insurance for all the employees

EMPLOYEE LOYALTY & LONG-TERM BENEFITS

Seniority Salary Increase Tiers

Private Health Care Loyalty Incentive

Vacation Voucher Benefit

Additional information: Candidates who meet the above conditions can send their CVs in English to hr@antoris.mk