Technical Services Manager

4 days ago

City Of Yarra, Australia Syntro Pty Ltd Full time
Job Title: Technical Services Manager

At Syntro Health, we are seeking an experienced Technical Services Manager to oversee the installation qualification, operational qualification, and process qualification of equipment and facilities in our laboratory and technical services department.

Key Responsibilities:
  • Preparation of IQ, OQ, and PQ documents for new equipment
  • Preparation and execution of cleaning validation protocols for equipment and facilities
  • Preparation and maintenance of validation SOPs
  • Assistance in facility maintenance and repairs, including requalification requirements
  • Overseeing warehouse, cool room, refrigerator, and freezer temperature mapping activities
  • Maintenance of the master validation plan and equipment validation registers
  • Assistance in the qualification and build of our new sterile facility
  • Participation in client and regulatory audits
  • Assistance with third-party compliance audits, with a focus on validation requirements
  • Participation in internal quality steering committee meetings and operations meetings
  • Training of quality staff and manufacturing staff in equipment and facility qualification requirements

This is a senior role within the company, requiring a strong understanding of GMP, cleanroom, and equipment qualification, with demonstrated prior experience in a similar role within the pharmaceutical industry.

Requirements:
  • More than 3 years' experience in validation or technical services departments within the pharmaceutical industry
  • Proven track record in the preparation of qualification documents, including for sterile manufacturing operations
  • Strong understanding of GMP, cleanroom, and equipment qualification

We are looking for an enthusiastic individual who is passionate about delivering high-quality technical services and ensuring compliance with regulatory requirements.

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