Lead - External Supply Quality Assurance (ESQA) - ANZ

Summary about this job

Detail information about job Lead - External Supply Quality Assurance (ESQA) - ANZ. Terms and conditions vacancy

• Leading global Animal Health company
• Innovative technical team with a strong supportive culture
• Great Career oportunities

The Role

Based in Sydney (Rhodes), Melbourne  (Parkville) or Auckland, the role primarily involves Quality Oversight at External Manufacturing sites (Scheduled visits), maintaining oversight for external manufacturer’s quality systems as they relate to Zoetis Drug Products and other Animal Health related products, and ensuring compliance with GMP / regulatory expectations.

Position Responsibilities

The responsibilities of the position fall into 7 key categories:

1. Contractor Management: Ensure contractors have applicable quality systems and comply with GMP/ regulatory requirements and Zoetis expectations for the product. Oversee GMP activities at contractors, such as Change Control, Deviation Management, Lot Approval,  Complaint Handling, Annual Product Reviews (APR), Stability Study, Validation Approval, Audit Support, Quality System Support and Metrics Review, etc.

2. New Product Introduction (NPI): Support the selection, audit and evaluation of potential contractors in the process of NPI. Assess the quality and compliance status at contractors prior to sourcing decision. Carry out due diligence Quality audits as directed and make recommendations on suitability of contractors and new business opportunities.

3. Product Transfers: Act as QA support to Product transfer teams and advise such teams on Zoetis expectation regarding process validation and Analytical Method Transfer Exercise (AMTE) performed at contractor. Supply QA approvals as required of the Transfer Plan and other activities, eg. Validation.

4. Regulatory: Support or conduct Regulatory compliance assessment at contractor. Support the process of documentation retrieval and collation to support Manufacturing Authorization renewals. Assess risk for Annual Reportable changes and CBE’s and communicate/approve risk assessments when required. Act as QA focal point for regulatory communications and changes.

5. Contract Process: Support the Supply Agreement contract process by developing, negotiating the Quality Agreement and co-ordinate the quality document agreement and approval route ensuring all key quality requirements are met. Maintain established Quality Agreements with contractors.
    
6. Other Contractor Assessments/Regulatory Inspections and Interactions: Facilitate and participate in assessment programs of contractors. Act as the Zoetis representative in the event of an external regulatory inspection involving Zoetis product at the contractor. Support contractor to develop and implement audit action plans, and track contractor CAPA plans to completion.

7. Development and Implementation of ESQA Guidelines & Policies: Contribute to the maintenance of the ESQA Quality System. Participate in developing ESQA Guidelines to ensure consistency of contractor standards across Zoetis. Ensure a consistent approach to the interpretation and implementation of GMP standards and Zoetis expectations.

Qualifications

• M.Sc., B. Pharm, M. Pharm or equivalent degree
• Fluency in English, Any other language is an asset

Prior Experience:

Minimum 3-5+ years of experience as follows:

• Working tin a relevant pharmaceutical industry role in QA and /or Manufacturing
• Experience that may include multifunctional, multi-site or other functional experience
• Working with multicultural, cross-functional work teams
• Experience in Quality Compliance functions
• Working knowledge of Quality Systems and Risk Management
• Knowledge of TGA, US FDA / EU GMP requirements impacting manufacturing operations
• Ability to work independently and in teams

Travel

Ability to travel 10-20%.

About Zoetis

Zoetis is the leading animal health company, dedicated to supporting its customers and their businesses. Building on more than 75 years of experience in animal health, Zoetis discovers, develops, manufactures and markets veterinary vaccines and medicines, complemented by diagnostic products and genetic tests and supported by a range of services. In 2017, the company generated annual revenue of US$5.3 billion. Zoetis has a local presence in approximately 70 countries, including 28 manufacturing facilities in 11 countries. Its products serve veterinarians, livestock producers and people who raise and care for farm and companion animals in 120 countries. For more information, visit www.zoetis.com

Only current residents of Australia or New Zealand will be considered for this role.

Please no recruitment agencies.

To apply, please provide a copy of your resume by Friday, 27th July to [email protected] quoting DCESQA0718