Technical Services Manager

2 weeks ago

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

Join Syntro Health, a leading provider of GMP investigational product manufacturing, warehousing, and distribution services to the pharmaceutical industry.

Job Summary:

We are seeking an experienced Technical Services Manager to oversee the installation qualification, operational qualification, and process qualification of equipment and facilities. The successful candidate will have a strong understanding of GMP, cleanroom, and equipment qualification with demonstrated prior experience in a similar role within the pharmaceutical industry.

Key Responsibilities:
  • Preparation of IQ, OQ, PQs, and Work Instructions for new equipment
  • Preparation of cleaning validation protocols and overseeing their execution for equipment and facilities
  • Preparation and maintenance of validation SOPs
  • Preparation and updating of User Requirement Specifications (URS), Site Master File (SMF), and Quality Manuals
  • Assisting in facility maintenance and repairs as required including any requalification requirements
  • Overseeing warehouse, cool rooms, refrigerator, and freezer temperature mapping activities
  • Maintaining the master validation plan and equipment validation registers
  • Assisting in the qualification and build of the company's new sterile facility
  • Participating in client and regulatory audits
  • Assisting with third-party compliance audits with specific emphasis on validation requirements
  • Participating 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, and the successful candidate will require a strong understanding of GMP, cleanroom, and equipment qualification with demonstrated prior experience in a similar role within the pharmaceutical industry.

About Syntro Health:

Syntro Health provides the local and international pharmaceutical industry with c GMP investigational product manufacturing, warehousing, and distribution services. Located in a convenient inner-city location adjacent to public transport, the company is looking for an experienced Technical Services Manager to oversee the installation qualification, operational qualification, and process qualification of equipment and facilities.

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