Senior Quality Assurance
vor 10 Stunden
Senior Quality Assurance (QA) Compliance OfficerPhebra Pty Ltd develops, manufactures, and supplies high quality and innovative pharmaceuticals to meet the requirements of the hospital specialty pharmaceutical market.
At Phebra, we create critical medicines which save and improve lives.
Together with manufacturing medicines, Phebra collaborates with hospitals in developing sought after therapeutic solutions.
It partners with companies to bring critical medicines to Australia.
Phebra also supplies and out-licenses products globally across the Pacific region, Asia, Europe, Canada, South America, and the Middle East.
Working with Phebra, you will have an opportunity to truly contribute and make a difference as we continue to expand locally and globally Our head office and manufacturing facility is based in Lane Cove, Sydney.
The location holds our warehousing, manufacturing, laboratory testing, and office environments.
The Lane Cove site hosts 130 employees and supports the health of Australians by supplying over 65 medicines in critical therapeutic areas.
The Role We are seeking an experienced and motivated Senior QA Compliance Officer, who will report to the QA Compliance Manager and sit within our Quality Department working alongside QA Operations, Validation, Technical, Quality Control, and others within the manufacturing business.
The Senior QA Compliance Officer role requires a depth of experience from all aspects of QA and Compliance, especially in the areas of quality assurance, auditing, and supplier approval.
Major Functions of the role include (but are not limited to): Initialising, writing, and reviewing Standard Operating Procedures relevant to QA Compliance.Actively seeking opportunities for continuous improvements to the quality systems through CAPA program.Be a lead trainer for GMP training and SOPs to maintain and improve company compliance.Be lead auditor for internal and external GMP Audits, including scheduling.Track audit findings and corrective actions and preventative action plans to close out.Oversee GMP Agreements process as part of Supplier Management.Undertake product quality complaint investigations.Obtain TGA GMP Clearance for overseas suppliers.Who are we looking for? Our ideal candidate would be someone who can think outside of the box, be pragmatic and solutions-oriented, and who is agile and flexible in approach as well as having the following capabilities and skills:
Minimum of 5 years' experience working in pharmaceutical quality assurance (or equivalent).Experience working within pharmaceutical facilities.Experience with auditing (internal/external) within GMP environment.Good knowledge of GMP principles and practices.Experience with technical aspects of cGMP administration, including continuous improvement of QMS systems.Strong computer literacy and strong written and verbal communication skills in English.A strong commitment to product quality and a continuous improvement mindset.A high level of motivation to achieve quality and efficiency targets.Full working rights in Australia are essential – if you have a temporary visa please address subclass and expiry during your application.What do you get? We offer a competitive base salary depending on experience and suitability with the above requirements.
Additional employee benefits include:
Annual discretionary bonus, based on individual and company performance.Novated lease administration options.Free parking at work.Annual paid volunteer day to assist a charity of your choice.Access to free annual flu vaccinations.Training and development opportunities.If the above role sounds like something you may enjoy, and you would like to apply please send through a resume and cover letter by clicking on "apply now" and our People & Culture Manager, Kelly Lawrence, will be in contact to discuss your application should your application be shortlisted.
Phebra is an equal opportunities employer, we are committed to diversity and inclusion within the workplace and believe that a diverse team with unique perspectives, ideas, and experiences should be valued.
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