Process Specialist

at  Argenta

ABOUT US

We are in the animal health business, partnering with our clients in the areas of research and development (R&D) and manufacturing to produce pharmaceuticals for both farm and companion animals. Originally founded in 2006 by a New Zealand chemist, Argenta’s vision is “Healthier Animals, Sustainably”. Our recipe for success has been the uniqueness of our vision and our people. Argenta now has operations across the globe with locations in New Zealand, the United States, Scotland, Germany and Spain with over 600 employees and still continuing to grow!

QUALIFICATIONS

• BSc. in Chemistry, Pharmaceutical Technology, Pharmacy, Chemical Engineering or equivalent scientific discipline.
• MSc or PhD, desirable

• Provide technical product / process oversight, from raw materials to primary packaging. Ensuring that current, and historical knowledge pertaining to product lifecycle is documented in accordance with cGxP, regulatory and internal frameworks.
• Act as a SPOC (Single Point of Contact), for assigned products – for both local and global partners.
• Project manage the technical introduction of new technology / equipment, ensuring activities are completed to internal & external framework(s)
• Perform technical deviation investigation(s) – including, but not limited to customer complaints; OOS (Out of Specification); OOE (Out of Expectation) – ensuring robust CAPA’s (Corrective Action; Preventive Action) plans are defined and implemented.
• Collaborating with internal stakeholders, participate in the APR (Annual Product Review) – providing technical expertise on product parameters & deviation trends.
• Complete product specific risk analysis; identify critical product parameters and prepare internal reports as required that monitor, analyse & recommend corrective action.
• Oversee & monitor the process of cleaning methods for assigned products.
• Collaborating with key local & global stakeholders, ensure continuous process / product / cleaning validation to ensure products assigned are in a constant state of validation.
• Support continued process verification using data trending and statistical analysis, including tracking and trending of critical parameters and in process controls.
• Manage the technical transfer of products to third party manufacturing partners.
• Author technical documents (i.e. Process Instructions; Policies & Procedures) for the Dundee facility, in accordance with cGxP standards.
• Support the continuous improvement platform, by role modelling, coaching & training associates to build technical knowledge, identify trends / gaps and develop solutions.
• Comply with all company local and global policies including Quality frameworks, Red Book, and health, safety and environment (HSE) policies.
• Perform any other duties or serve in such other capacity as may be determined by Company management.

Relationship Management

• Develop and nurture strong relationships to ensure optimal performance.
• Work collaboratively, engaging with key stakeholders to facilitate delivery and compliance with the manufacturing frameworks.
• Communicate with stakeholders the impact of market change and potential effects on manufacturing design and development, recommending solutions without compromising quality or service while optimising costs.
• Contribute to new business initiatives and projects, review and communicate the impact on manufacturing activities.