Ø Leading Contract Manufacturer
Ø Exciting Permanent Opportunity
Ø Fast Paced, Dynamic Working Environment
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 to work in a challenging role. The successful candidate will be reporting to the Head of Quality and managing a team of QA officers. The candidate will have superior attention to detail and a demonstrated subject matter expert for manufacturing & packaging processes to comply with local 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:
Ø Manage Release for Supply of products in line with PIC/S and TGA
Ø Mange Review of batch documentation and release of batches of Intermediates, Bulk & Finished Products and packaging materials in compliance with all relevant regulatory standards
Ø Manage, sustain and improve site compliance to regulatory requirements such as TGA, DoAW (NSW Food Authority), HACCP
Ø Manage Corrective and Preventative Actions system and follow up on CAPA plans
Ø Investigate and troubleshoot any production incidents
Ø Manage Customer Compliant System and Process Deviation Systems and liaise with sponsors
Ø Create, review & / or authorize all relevant process deviations required during batch document review or batch release activities
Ø Participate in Investigations including Root Cause Analysis & Risk Assessments
Ø Manage a team of QA officers & report on Quality Key Performance Indicators
Ø Manage Internal Audit Program in line with approved standard operating procedure
Ø Manage Product Quality Reviews and liaise with sponsors
Ø Participate in customer / regulatory / certification audits and close out
Ø Perform Compliance Trend Analysis as defined in relevant organizational procedures
Ø Promote and develop innovative solutions to improve QA performance and costs
Skill Requirements Include:
Ø A tertiary qualification in Science or equivalent, or demonstrated operational experience of at least 5 Years in a pharmaceutical laboratory &/or QA role
Ø A superior knowledge of and ability to interpret current GMP / GLP requirements within the Complementary Healthcare industry
Ø Excellent knowledge of latest PIC/S and relevant TGA guidelines
Ø Excellent attention to detail, the ability to take the initiative within the constraints of regulations and a high work ethic and able to observe WHS standards
Ø Experience working with SAP will be an advantage
Ø Excellent written, oral and interpersonal communication skills, effective team player within a challenging environment
Ø Flexible; able to work in an environment where priorities and deadlines change on a frequent basis
Ø Excellent computer literacy, including LIMS & Microsoft applications, especially Word & Excel
This is a great opportunity for someone with good experience and attitude to join our hardworking, cohesive and friendly team. A strong awareness of Chinese culture and language would also be an advantage.
If you feel you have the above experience and skill set, submit your covering letter and resume via Seek.
Only applicant selected for interview will be contacted.
All other applicants are thanked for their interest.