Antal International is a Multinational Headhunting Company with more than 140 offices in 40 countries.

Life Science is a Team specialized in profiles with a Scientific and Engineering background in Manufacturing, Production, Engineering, SCM, Research and Development, Medical, Quality and Technical-Commercial in Pharmaceutical, Pharmaceutical Chemistry, Biotech, Chemical, Cosmetic, Medical, Diagnostic, Plastic Rubber, Food sectors.

The Company

For a pharmaceutical company, we are looking for a

Sterility Assurance Supervisor

The Role
 

The Sterility Assurance (SA) Supervisor is responsible for fostering SA principles across site.

• Generate and maintain the contamination control strategy;
• Promote understanding of and compliance to SA regulations such as EU Annex 1 & the FDA's aseptic processing guide;
• Define, coordinate, and improve the Environmental Monitoring & APS programs;
• Ensure that suitable aseptic comportment/training/oversight programs are in place and effective;
• Ensure that all sterilisation processes are being managed compliantly;
• Conduct risk assessments and improvement programs to maintain SA practices stay aligned with current and future regulatory expectations;
• Manage company deviations;
• Support the Batch Record revision;
• To prepare and periodically review Standard Operating Procedures, Protocols, Reports and other documents as may be required;
• Contributes to periodical presentations of KPI measurements and their interpretation, as applicable to the QA Department;
• To Supports nominated Qualified Person/s in the release of pharmaceutical products to the market;
• Coordinate QA operation personnel.

Personal Attributes

• Minimum Science based degree in Chemistry, Pharmacy or Microbiology;
• Substantial experience working of minimum 5 years in a pharmaceutical Quality department on a sterile site. This position requires deep understanding and proven application of cGMP regulations and international guidelines in a sterile production setting. This knowledge needs to be combined with clear decision making, pragmatism aligned with quality risk management principles to demonstrate release of product appropriate for commercial use;
• Substantial Quality Assurance experience and 'hands-on' knowledge of all Quality Systems required for a sterile manufacturing facility;
• Understands the principles of sterile manufacturing;
• Flexibility to meet changing needs and priorities of the business with experience of developing and influencing business strategy;
• SAP advanced user or admin will be considered a plus.

Location:             Malta

Please send your resume to: [email protected]

If not in possession of all the requirements indicate as reference: SELF-CANDIDATION

Applications deemed online will be contacted within 30 days of receipt of the application.

Thanks in advance to all those who want to send us their CV, in case of failure to call, we will consider the professional profile for any future needs.