Validation Associate / Engineer (Part-Time)

Sphere Healthcare is a leading Australian-owned contract manufacturer of Complementary Healthcare Products, based in Sydney with easy access to major motorways.

We are seeking a Validation Associate, who displays initiative and is self-motivated, to join our close-knit and highly skilled team.  The successful candidate will execute validation protocols for manufacturing processes, perform qualification activities on existing equipment and work with key internal stakeholders to ensure any new equipment is qualified in a timely and compliant manner.

Role Responsibilities:

Ø  Review and approve GMP validation documentation to ensure compliance with regulatory requirements and best practice

Ø  Assist with Risk Assessment Processes to support the business

Ø  Generate validation protocols and reports ensuring practices meet TGA requirements

Ø  Validation Protocol Preparation including URS, DQ, IQ, OQ & PQ

Ø  Maintenance of Validation Project Plans, including Site Validation Master Plan

Ø  Assist in the management of validation activities associated with changes to existing and new processes

Ø  Execution of Validation activities and report preparation

Ø  Develop validation plans, SOPs, programs and policies

Key Requirements:

Ø  Tertiary qualified in either Science, Engineering or related discipline

Ø  (Graduates in their final year will be considered for this role)

Ø  Previous experience within the Pharmaceutical or Complementary Medicines industry an advantage

Ø  Knowledge of, and ability to interpret validation principles and regulatory

requirements

Ø  Experience in process, cleaning and equipment validation

Ø  Knowledge of continuous improvement and risk based methodologies

Ø  Excellent Communication and Organisational skills

Ø  Demonstrated effective Project Management and superior Computer Literacy

Sphere Healthcare is an equal opportunity employer that values diversity.  This is a great opportunity for someone with good experience to join our hardworking team and we encourage all suitable applicants to apply.

If you feel you have the above experience and skill set, submit your covering letter and resume to: hr@spherehealthcare.com.au.

Only applicants selected for interview will be contacted.

All other applicants are thanked for their interest.

Maintenance Fitter (Bilingual)

Sphere Healthcare is a leading contract manufacturer of Complementary Healthcare Products, located in Sydney with easy access to major motorways.

We are recruiting for experienced and motivated individuals to work within our Engineering department. Individuals will be responsible for the set up of new plant and equipment, fitting and assembling fabricated and machined parts into existing machinery and reducing equipment downtime.

Key Responsibilities:

Ø  Able to interpret engineering drawings/schematics and specifications

Ø  Install new equipment and perform approved modifications to expand infrastructure as needed

Ø  Respond quickly to all service requests and efficiently repair mechanical systems

Ø  Set up and operate of processing equipment

Ø  Set guides, stops and other controls on machining tools

Ø  Plan and carry out line change overs to meet production needs

Ø  Repair mechanical equipment such as gear boxes, mechanical seals and conveyor systems

Ø  Perform preventative maintenance tasks relating to equipment

Ø  Check fabricated and assembled parts for accuracy

Ø  Attend to breakdowns and troubleshoot faults

Ø  Ensure all plant and equipment is running smoothly

Ø  Assess systems and suggest modifications to prevent future issues

Ø  Operate the appropriate equipment and tools found in an engineering department

Ø  Complete documentation relating to repairs and maintenance in a GMP compliant manner

Ø  Follow SOP’s for equipment and services

Skills, Experience and Attributes:

Ø  Relevant certificate/qualifications from recognised institution

Ø  Knowledge of mechanical equipment with experience with a GMP/TGA environment

Ø  Pneumatic systems, hydraulics and packaging machinery experience

Ø  Restricted electrical license is an advantage but not essential

Ø  Previous experience as a mechanical fitter / fitter and welder

Ø  Adaptable individual with good work ethic

Ø  A commitment to workplace safety

To obtain an interview you will be required to successfully complete the GMP Introduction and Selection quiz.  Exceptional written and verbal communication skills in both English and Mandarin, with the ability to translate drawings and documents could make you the successful candidate for this role.

If you are interested in the opportunity submit your covering letter and resume to:

hr@spherehealthcare.com.au

Only applicants selected for interview will be contacted.

All other applicants are most grateful for their interest.