Activ Pharmaceuticals, a part of the Activ Pharmaceutical Group, is based in Smeaton Grange and manufactures both cosmetic and therapeutic liquid and cream products.

Delivering premium, high-performing products for emerging and established companies, Activ Pharmaceutical Group has the innovation and experience to take a product from an intangible concept all the way through to the shelves of the commercial market.

Our manufacturing plants are located across New South Wales and Victoria, Australia.

We are now recruiting for a Quality and Compliance Specialist to work across the operations group, collating information and compiling into reports with assessments for compliance and recommendations.

Responsibilities of the position will include:

- Provide support in the introduction of new products into the facility through appropriate change control, risk assessment and document development and implementation.

- Manage change controls ensuring GMP and regulatory compliance.

- Prepare and maintain starting material and finished product specifications.

- Develop qualification/re-qualification protocols, manage qualification schedule, lead and coordinate cross-sectional teams in qualification activities and prepare reports in line with company requirements.

- Maintain SOPs up to date.

- Participate in GMP inspections, including internal and third party.

- Support compliance requirements and regulatory changes.

- Support technical projects to meet global regulatory requirements.

- Assist in annual product reviews.

- Conduct risk-based investigations and co-ordinate any CAPA activities.

- Support continuous improvement in the company’s PQS and QA processes.

The successful candidate requires:

- Bachelor’s degree in chemistry, pharmacy or related sciences.

- 3+ years of demonstrated quality assurance experience in pharmaceutical/complementary medicines industry.

- Sound knowledge of qualification requirements to meet GxP guidelines with experience in protocol development.

- Experience in operating across cross-functional team environments.

- Strong written and verbal communication skills.

- Demonstrated analytical and problem-solving skills with a high level of attention to detail.

In return, Activ Pharmaceuticals will offer:

• An immediate start working a 38 hour week

• Employee Assistance Scheme

• An equitable and ethical workplace

• On site parking

• The support of a professional team working in a safe environment