QA Shopfloor Officer at Pharmathen · Sapes

Founded in 1969, Pharmathen has grown into a leading developer and manufacturer of specialized pharmaceutical products and one of the largest vertically integrated companies in advanced drug delivery technologies. With a strong international presence, we remain committed to improving people’s lives through innovation and access to affordable, high-quality medicines. Today, our products reach patients in more than 90 countries worldwide, supporting better health outcomes every day.

Pharmathen employs more than 1,600 people from over 27 different nationalities, reflecting a diverse and international workforce. Our achievements are driven by strong scientific expertise, high ethical standards, and the dedication of our people, who share a commitment to improving patient lives.

Pharmathen offers a great opportunity for career development and is seeking to recruit a QA Shopfloor Officer to join our team at our Sapes premises.

As a QA Shopfloor Officer, the ideal candidate will ensure compliance with Good Manufacturing Practices (GMP) by providing real-time supervision and oversight of production activities. This position ensures that manufacturing processes meet quality assurance standards, and that deviations, non-conformities, and potential risks are identified and addressed promptly. The Shop Floor Quality Assurance Professional will act as the first line of defence against quality issues, working closely with production teams to drive a culture of continuous improvement and compliance.

More particularly:

What you’ll do:

• Ensure real-time quality oversight during production, packaging, and cleanroom operations and confirm adherence to standard operating procedures (SOPs), batch records, and GMP regulations
• Conduct routine in-process checks (e.g., environmental monitoring, growing compliance, , and line clearance)
• Identify and escalate quality assurance risks such as potential cross-contamination, or mix up of products or materials or any non-compliance issues
• Enforce proper documentation practices (GDP) and real-time batch record completion
• Support GMP training and mentorship of production personnel on quality-critical operations
• Work with production teams to improve process robustness and reduce recurring quality issues
• Perform on-the-spot batch record reviews to identify and correct discrepancies
• Collaborate with production to reduce human errors and procedural violations
• Provide QA presence during critical process steps)
• Assist in regulatory inspections (e.g., EMA, FDA, local authorities) by ensuring shop floor readiness
• Conduct internal GMP walk-throughs and provide feedback to management on compliance gaps
• Support audit response actions related to shop floor findings and implement sustainable fixes

Minimum Qualifications:

• Bachelor’s degree in Pharmacy, Chemistry, Biology, or a related scientific field
• 3+ years of experience in pharmaceutical manufacturing or QA

Job-Specific Skills:

• Excellent communication skills and ability to enforce quality requirements on the shop floor
• Experience with in-process controls during production and packaging
• Competence in reviewing and verifying batch records, line clearance, and shopfloor documentation.
• Strong knowledge of EU GMP, Annex 1 (sterile products), and quality risk management (QRM)
• Ability to work in a fast-paced, production-driven environment with strong problem-solving skills

What you'll gain:

Involvement in a high-caliber, team-oriented and dynamic atmosphere

Exposure to challenging business issues and practices

Great opportunity to leverage and develop your business knowledge and skills

Join our team and experience the unique Pharmathen’s culture that gives you the opportunity to innovate, to make decisions, to achieve your own potential and to chart your own career.

Pharmathen is an equal opportunity employer. We welcome applications regardless of gender, race, age, religion, sexual orientation, and national origin.