Shop Floor Quality Assurance Professional (Rodopi)

Description

Founded in 1969, Pharmathen has grown to become one of the largest, vertically integrated developers of complex drug delivery technologies and is among the top 50 pharmaceutical research companies in Europe.

The company has one of the most extensive and advanced pipelines of long acting injectables (LAI), sustained release and ophthalmic formulations.

Pharmathen’s highly diversified portfolio consists of over 90 commercialized products, which are produced in its US FDA and EU-approved manufacturing facilities in Greece, serving 250 customers and accessed by patients in more than 90 countries worldwide.

Pharmathen proudly employs more than 1,600 people from over 28 different nationalities, with 54% of its total workforce and 66% of its Research Operations Team being female. The company’s enduring success is attributed to a passion for creativity, strong ethics, and the dedication of its people, who share a commitment to the company's vision of making a difference in people’s lives.

Due to continuous growth and expansion, Pharmathen Pharmaceuticals offers a great opportunity for career development and is seeking to recruit a Shop Floor Quality Assurance Professional to join our Quality Assurance team at Sapes, Northern Greece premises.

The Shop Floor Quality Assurance Professional ensures compliance with Good Manufacturing Practices (GMP) by providing real-time supervision and oversight of production activities. This position ensures that manufacturing processes meet sterility assurance standards, and that deviations, non-conformities, and potential risks are identified and addressed promptly. The Shopfloor Quality Assurance Professional will act as the first line of defense 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
• Supervise every manufacturing process to confirm adherence to standard operating procedures (SOPs), batch records, and GMP regulations
• Conduct routine in-process checks (e.g., environmental monitoring, growing compliance, aseptic interventions, and line clearance)
• Identify and escalate sterility assurance risks, potential cross-contamination, or non-compliance issues
• Enforce proper documentation practices (GDP) and real-time batch record completion
• Monitor sterile product manufacturing, including cleanroom behavior, aseptic techniques, and interventions   
• Participate in media fills, smoke studies, and environmental monitoring programs to maintain sterility assurance
• Ensure adherence to cleaning validation protocols and sanitization procedures in classified areas
• Address sterility failures, deviations, or operator errors and support root cause analysis (RCA)
• Investigate deviations, out-of-specifications (OOS), and out-of-trend (OOT) results occurring on the shop floor
• Conduct real-time risk assessments and implement corrective and preventive actions (CAPAs)
• 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 (e.g., sterile filtration, filling, lyophilization)
• 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

Requirements

The ideal candidate should have:

• Bachelor’s degree in Pharmacy, Chemistry, Biology, or a related scientific field
• 1-3 years of experience in pharmaceutical manufacturing or QA (sterile products experience preferred)

Job-Specific Skills

• Excellent communication in English language (writing & speaking)
• Strong knowledge of EU GMP, Annex 1 (sterile products), and quality risk management (QRM)
• Hands-on experience with sterility assurance programs, aseptic processing, and cleanroom monitoring
• Ability to work in a fast-paced, production-driven environment with strong problem-solving skills
• Excellent communication skills and ability to enforce quality requirements on the shop floor
• Clear explanation of quality requirements, deviations, and corrective actions to production teams, regulatory auditors, and other stakeholders
• Informed and risk-based decision-making in real time to maintain quality and compliance without unnecessary production delays
• Professional conflict resolution between production and QA teams while ensuring compliance
• Effective prioritization of tasks to balance in-process checks, documentation, and audits
• Identification of areas for process optimization and proactive suggestion of improvements

Benefits

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.