QA Operations Officer

QA Operations Officer

(Ref: QAO_0225)

 

About the company

RAFARM is an innovation-driven, dynamically growing pharmaceutical company and a well-established European manufacturer with an outward-looking orientation that invests 13% of net turnover in Research and Development. We introduce high technology in our state-of-the-art sterile manufacturing plant and create new production lines with cutting-edge technology and robotic equipment. RAFARM is a place where our people evolve and are full of passion and interests. We are a dynamic team that empowers talent, embraces diversity, and accelerates development.

 

About the role

We are seeking a meticulous and dedicated QA Operations Officer to join our Quality Assurance department. The ideal candidate will oversee quality processes, dossier submissions, and production compliance.

The role main accountabilities will be the following:

• Responsible for identifying the needs for new written procedures or the revision of existing procedures related to all processes managed by the Quality Operations team, including procedures associated with aseptic manufacturing.
• Participates in the monitoring and maintenance of the deviation investigation records arising from all relevant processes and activities, including aseptic manufacturing processes, as well as in the distribution of copies to the relevant departments and customers.
• Participates in the investigation and oversight of Out-of-Specification (OOS) and Out-of-Trend (OOT) results, including cases related to aseptic manufacturing processes.
• Participates in the execution of various assessment and evaluation studies related to product manufacturing processes, including aseptic manufacturing processes, where validation of their reliability is required due to their criticality (e.g., Media Fill Studies and Visual Inspection Personnel Validation Studies).
• Participates in risk assessments and in the management of aseptic interventions, as well as in the planning and execution of aseptic process simulations.
• Responsible for providing guidance and training to personnel involved in Quality Operations processes, including requirements and procedures related to aseptic manufacturing.

• BSc in chemistry, chemical engineering or relevant scientific discipline
• 1-2 years of relevant experience in a Quality Assurance department at a pharmaceutical manufacturing industry
• Highly detail-oriented and organized, able to work both independently and as a team player with a positive attitude
• Effective communication and facilitation skills to ensure the successful outcome for investigations, risk assessments and other evaluations
• Ability to meet varying deadlines
• Experience in working within SAP environment would be considered an asset

Why Join Us

• Competitive Compensation
• Private Health Insurance
• Career Development Opportunities
• Work-Life Balance
• Company Bus
• Innovative Work Environment
• Community Engagement
• Recognition and Rewards

 

At RAFARM, you'll be part of a passionate team dedicated to making a positive impact on global health. You’ll grow your career in a dynamic and innovative environment where your contributions matter.

After the collection and evaluation of all CV's, we will contact only those candidates who meet the requirements of the position to be filled in order to set an appointment for an interview. All applications are considered strictly confidential.