Senior Qa & Pv Associate

About the Company:

Founded in 2004, Generic Health is one of Australia’s leading and most trusted generic pharmaceutical companies. It is 100% owned by Lupin Limited, a top 10 ranked generic company in the world, with sales in excess of $2 Bn.

With our headquarters in Melbourne, Generic Health provides a comprehensive product range of high-quality and affordable generic medicines to consumers and healthcare professionals across Australia. Generic Health markets and distributes over 180 generic products and OTC products under its prescription and Pharmacy Action branding, sourcing products from India, Europe and Australia.

At Generic Health, we pride ourselves on a workplace culture that promotes diversity, inclusion, innovation, creativity and excellence.

As the Senior QA & PV Associate, you will be responsible for leading and driving the Quality Assurance and PV activities across the business. This opportunity would ideally suit someone who has an eye for detail, a strong commitment to process and enjoys working in a collaborative team environment. This role will see you work with multiple teams and external parties to drive positive outcomes for all matters relating to Quality Assurance and Pharmacovigilance.

Your key responsibilities will include:

• Perform “release to market” activities for all incoming products. 
• Work with internal teams and external parties to prioritise product release and resolve issues.
• Co-ordinate product recall or defect actions.
• Work with internal and external teams to manage deviations, CAPAs and non-compliance requests, including performing and reviewing risk assessments.
• Assist with the change control review and approval process.
• Work with manufacturers and suppliers to ensure product compliance.
• Assist in the maintenance and review of Product Quality Reviews and stability data for products. 
• Conducting product quality complaint reviews, investigations, feedback and reporting. 
• Assist with TGA's pharmacovigilance compliance, including company-wide training.
• Support internal and regulatory audits of the pharmacovigilance system.
• Assist with the preparation, review and maintenance of Pharmacovigilance Agreements.
• Implement and maintain systems, policies and procedures.

About you:

The experience and attributes we welcome include:

• Bachelor of Science or equivalent tertiary qualification. 
• 5-10 years’ experience in pharmaceutical industry. 
• Extensive knowledge of quality assurance and pharmacovigilance requirements. 
• Competence in technical writing including SOPs, work instructions and quality investigation reports.
• Strong analytical and problem-solving skills. 
• Strong organisational/time management skills and ability to meet deadlines.
• Team player with effective collaborative skills.
• Excellent written and verbal communication skills. 
• Intermediate Microsoft Office skills, including Word and Excel. 

What we offer:

In return, you’ll be provided with:

• A collaborative and supportive team and flexible work environment.
• A positive company culture. 
• Career development opportunities.
• Competitive salary.
• Modern workplace.
• Hybrid, 3 days a week on-site.
• We are close to public transport and shops.

Employment requirements:

• Visa sponsorship is not available for this position. For a continuing position, you must be an Australian or New Zealand citizen or an Australian Permanent Resident.
• Your employment is conditional upon the completion of pre-employment/background checks.

If this sounds like the right opportunity for you, please submit your resume and a cover letter outlining your suitability for the role.

We look forward to hearing from you!