Sphere Healthcare is a leading contract manufacturer of Complementary Healthcare Products, based in Sydney with easy access to major motorways.
We have the perfect opportunity for an individual looking for full time work in a challenging role. The successful candidate will be reporting to the QA Manager and will be responsible for the performance of routine batch document review and release of Intermediates, Bulk & Finished Products within the QA Team.
The candidate will have superior attention to detail and a demonstrated ability to critically review manufacturing & packaging documentation with respect to compliance to all Regulatory standards, while having the flexibility and capacity to operate both autonomously and as a team player, depending on the dynamic challenges of the day.
Key Responsibilities Include:
Review of batch documentation and release of batches of Intermediates, Bulk & Finished Products in compliance to all relevant regulatory standards
Create, review & / or authorise all relevant Process Deviations required during batch document review or batch release activities
Facilitate Process Deviation Investigations including Root Cause Analysis & Risk Assessments
Contribute to the collation & presentation of all QA Personal & Operational Key Performance Indicators
Contribute to the Internal Audit schedule and stakeholder feedback
Perform Compliance Trend Analysis as defined in relevant organisational procedures
Promote and develop innovative solutions to improve QA performance and costs
Skill Requirements Include:
A tertiary qualification in Science or equivalent, or demonstrated operational experience of at least 5 Years in a pharmaceutical laboratory &/or QA role
A superior knowledge of and ability to interpret current GMP / GLP requirements within the Complementary Healthcare industry
Excellent attention to detail, the ability to take the initiative within the constraints of regulations and a high work ethic
Excellent written, oral and interpersonal communication skills, effective team player within a challenging environment
Flexibility; ability to work in an environment where priorities and deadlines change on a frequent basis
Excellent computer literacy, including LIMS & Microsoft applications, especially Word & Excel
Able to observe WHS standards
Good written and verbal communication skills together with knowledge of current GMP/ GLP as well as basic computer word processing, spreadsheets, could make you the successful candidate for this role.
If you feel you have the above experience and skill set, submit your covering letter and resume via Seek.
Only applicants selected for interview will be contacted.
All other applicants are thanked for their interest.