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Role Description:

The main responsibility of the the Quality Assurance Pharmacist is to is to ensure continued compliance of the technical aspects of the business. The purpose is to ensure compliance with all the provisions of the Pharmacy Act, 53 of 1973, as amended and other legislation applicable to services which specially pertain to the scope of practice of a pharmacist, and the legislation applicable to the pharmacy

Key Performance Area include:

1. Contractor Management:

General: Ensure contractors have applicable quality systems and comply with GMP/regulatory requirements and Zoetis expectations for product. When required communicate applicable GMP , regulatory standards and Zoetis expectations to contractors and assist them in the adoption of these requirements into their local procedures and practices;

• Change Control: assess product related change proposals from a quality and GMP stand point. Process the acceptable changes to COQA Regulatory Compliance and manage the timing of implementation of change at contractor; If required, act as the SCNM.
• Deviation Management: evaluate independently the impact of all significant deviations generated at the contractor and negotiate any actions required. If necessary, initiate the “Notification to Management” process and process through the Site Quality Review Team (SQRT) and the Area Quality Review Team (AQRT). Ensure appropriate communication to External Supply/VSOT enabling on time initiatives to avoid market stock-outs; with guidance, is expected to build and present the summary of the events and recommendations for the AQRT.
• Market Actions: The link to the contractor for Zoetis quality decisions & actions and involved in the co-ordination/execution of any market action (recall/stop distribution/stop release) internally and with the contractor.
• Lot approval: where required for South African contractors, perform the lot disposition for Zoetis products which have been released to Zoetis by the contractor in accordance with local regulations;
• Complaint handling: manage independently the external market complaint process by ensuring that all justified complaints requiring investigation at the contractor are answered in a timely manner and that the contractor investigation report is appropriate and meeting requirements, Manage compliants in PV Works and if requested approve other colleagues entries as 2^nd approver;
• Annual Product Reviews (APR): ensure that APRs are timely generated by the contractor for Zoetis products and that required corrective or preventive actions are defined and implemented in a timely manner; Ensure contractor QA expectations for Zoetis MAH review are met.
• Stability: Ensure that the contractor is operating a Stability Surveillance program for Zoetis products in accordance with GMP requirements and that any Out of Specification (OOS) stability results are promptly handled and communicated;
• Validation approval: review and endorse any validation activities directly involving Zoetis products independently;

• Audit support: Co-ordinate and facilitate the Zoetis Global Compliance Quality Audit (GCQA)audit process at the contractor. Ensure a clear and successful audit outcome and define appropriate action plans for improvement. Periodically follow-up and ensure action closures.; Evaluate discontinuation of contractor if needed.

• Quality System support: visit the contractor/stay in communication and promote strong Quality partnerships with contractor. Define Quality Improvement Plans in order to support continuous improvements to the contractor quality systems. Review these plans with contractor management during Quality Visits and Business Review Meeting (BRM);
• Issue and review Metrics: Periodically assess independently the overall quality risk associated to the contractor. Act on adverse trends in order to improve contractor quality and compliance performance.

2. New Product Introduction (NPI)

• Support the selection, audit and evaluation of potential contractors in the process of NPI by supplying appropriate quality input..
• Assess the quality and compliance status at contractors prior to sourcing decision and prior to release of first batches.
• Review if lot disposition process is required and how long.
• Support the co-development initiatives for Quality and Compliance for contractor related activities.
• Carry out due diligence Quality audits as directed and make recommendations on suitability of contractors and new business opportunities.
• Follow up and ensure timely closure of due diligence CAPA’s in time with project plans

3. Product transfers (PNS)

• Act as QA support to Product transfer teams.
• Advise such teams on Zoetis expectation regarding process validation and 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
• Support or act as the Site Network Compliance Member (SNCM) within the Global Regulatory change control system for the contractors assigned as required.

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 in alignment with supply and internal technical agreements on time.
• Where required initiate Technical agreements between ESQA and markets and give guidance on requirements between a MAH and a contractor.
• Facilitate Pharmacovigilance agreements where needed.

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 audit involving Zoetis product at the contractor
• Ensure any impact on Zoetis product is communicated in a timely manner.
• Support contractor to develop and implement audit action plans in a timely manner, based on existing procedures and practices;
• Track contractor CAPA plans to completion. Proactively support GMP assessments and audits at contractors, report the outcome and ensure appropriate corrective and preventive actions are put in place.
• Where identified by other means eg Quality visit, complaints etc, propose potential GMP Improvement plans for contractors and assist with the implementation;
• In product defect situations the manager may be required to interact with GMP/licensing authorities as a representative of Zoetis Quality and be involved in drafting notifications for regulatory communications on product defects and subsequent actions.

7. Development and Implementation of ESQA Guidelines and policies:

• Contribute to the maintenance and 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 GxP standards and Zoetis expectations.

• Participate in Coordination of annual GCQA audit schedule for contractors

Reporting Structure:

Reporting to:  Director External Supply Quality Assutance EUAFME. Dotted line report to Regional Director South Africa

Number of direct reports: None

Minimum Requirements:

• A degree in Pharmacy
• Registered Pharmacist in South Africa
•  A minimum 6 to 8 years experience in Pharmaceutical industry with at least 4+ years in QA/QC type roles supporting commercial pharmaceutical operations, ideally in a production QA support, technical manufacturing projects or release roles;
• A valid driver’s license

Technical Skills:

• Contribute to the maintenance and of the ESQA Quality System;

• Participate in developing ESQA Guidelines to ensure consistency of contractor standards across Zoetis

• Demonstrate knowledge of a range of products and regulatory requirements in the diverse portfolio of products (ideally Animal Health).
• Shows strong negotiation and communication skills.
• Demonstrates potential to manage multiple projects, Must prioritize own work, to act and work independently and to report items as required to Team leader. 
• Have excellent organization skills and ability to prioritize colleagues
• Demonstrated experience managing complex quality and compliance activities in a manufacturing plant or with a contractor. 
• Potential personal leadership to manage cross functional projects.
• Demonstrated ability to resolve conflicts. 
• Takes initiatives and is proactive, persistent and purses to closure 
• Has a strong broad GMP and technical know-how to handle emerging issues. 
• Is diplomatic in communication with internal and external customers.
• Is customer oriented and willing to travel up to 20 %.

Competencies:

• Team player
• Lead change and innovation
• Demonstrates strong business acumen
• Strong analytical thinking, problem solving skills, attention to details
• Demonstrates strategic ability
• Honesty and consistency
• Shows high level of integrity in all customer related and business activities.