AddressCompany Overview:
Proclinical has partnered with a globally recognized leader in biotherapeutic solutions, dedicated to saving lives and improving the quality of life for people with rare and serious medical conditions.
The Elizabeth St, Melbourne CBD site is a newly established, state of the art global headquarters and centre for research and development facility designed to be a powerful catalyst for scientific discovery in Australia boasting seven stories of world class labs and numerous office spaces.
Overview:
The Senior Quality Associate, reporting to the R&D Batch Release & Audit Manager is responsible for the quality compliance and documentation deliverables of a major project surrounding the procurement of extensive new production and analytical equipment, installation of equipment and facility upgrades in accordance with Good Manufacturing Practice (GMP) requirements.
Team Size: 15 people
Duration: 6-month contract
Start Date: ASAP
Hours: Monday - Friday (standard)
Capacity: All on-site
WHV:Yes - open to candidates with 6 months working rights
Location: Elizabeth Street, Melbourne CBD
Role:
There are 4 roles:
2 x Senior Quality Associate - Validation
- Project – validation of large range of equipment
- Execute protocols
- Compliance review, work through data entries to see if they have been done correctly and check assumptions and conclusions are correct
Requirements:
- At least 1 yr in validation and pharmaceutical environment
2x Senior Quality Associate - GMP documentation
- Hundreds of documents generated from manufacturing for review and testing, and how they manage their equipment and processes
- Review documentation ensuring they are compliant with CSL expectations
- Seeking candidates with experience working in pharma facility
- Assisting with change controls and deviations
Requirements:
- 3-5 yrs experience in GMP / similar position
Benefits:
This is an enticing opportunity for an experienced pharmaceutical Quality Assurance Associate to join a high functioning team contributing towards all compliance activities relating to the qualification and validation program for the new manufacturing facility and testing labs towards securing site operational readiness and regulatory compliance certifications alongside the biggest pharmaceutical organisation in Australia.
Contact details:
If you are interested and would like to hear more about this position, please email Pamela on ************@proclinical.com or call 02 9054 7*** for more information.
About Proclinical:
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
Proclinical Staffing is an equal opportunity employer.
