Zoetis is a global animal health company dedicated to supporting customers and their businesses in ever better ways. Building on 60 years of experience as Pfizer Animal Health, we deliver quality medicines and vaccines, complemented by diagnostics products and genetics tests and supported by a range of services. We are working every day to better understand and address the real-world challenges faced by those who raise and care for animals in ways they find truly relevant.
Post : Executive, ESQA / Assistant Manager, ESQA (856500)
Job description
- Support activities of ESQA related with other Zoetis functions (e.g. GMS, GCQA) to effectively manage Quality / regulatory compliance in third party manufacturing and suppliers.
- Act as ESQA team member located at contractor’s site (person in place) in India to participate in investigation and support colleagues in quality management and oversight of 3rd party manufacturers in India as per Indian FDA / USDA / EU-GMP and other regulatory requriements.
- Ensure implementation of Zoetis expectations and requirements at 3rd party manufacturers and resolve differences to policies.
- Contractor Management - Maintain oversight for contract manufacturer’s quality systems as they relate to Zoetis product and ensure compliance with GMP/regulatory expectations. Review and approve documentation for the following:
- Change Control - assess product related change proposals from a quality and GMP stand point. Process the acceptable changes to ESQA Regulatory Compliance and manage the timing of implementation of change at contractor;
- Deviations - independently evaluate the impact of all significant deviations and negotiate any actions required. If necessary, initiate / escalate 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;
- Complaints - ensure all justified complaints requiring investigation are answered in a timely manner in PV works and that the contractor investigation report is appropriate and meeting requirements;
- Annual Product Reviews - ensure that APRs are generated timely and that any required corrective or preventive actions are defined and implemented in a timely manner;
- Stability - ensure that stability studies are performed for Zoetis products in accordance with GMP requirements and that any Out of Specification (OOS) stability results are promptly handled and communicated;
- Validation - review and endorse any validation activities directly involving Zoetis products.
- Contract Process - Negotiate a Quality Agreement and ensure all key quality requirements are met.
- Regulatory - Support or conduct Regulatory compliance assessment at contractor and collect necessary documentation to support Manufacturing Authorization renewals.
- Other Contractor Assessments - Facilitate and participate in Zoetis Quality Audits of contractor. Act as the Zoetis representative in the event of an external regulatory audit involving Zoetis product at the contractor. 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.
- Releasing batches in SAP and verification CoA’s and import documentation related to imported goods.
Candidate Profile :
1. Ideal candidates should possess the following skills or have experience in the following:
2. Experience that may include multifunctional, multi-site or other functional experience Working with multicultural, cross-functional work teams
3.Experience in Quality Compliance functions
4. Working knowledge of Quality Systems and Risk Management
5. Knowledge of Indian FDA, US FDA / EU GMP requirements impacting manufacturing operations
6. Ability to work independently and in teams
Additional Information:
Experience : 3-5 years
Qualification : M.Sc., B. Pharm, M. Pharm or equivalent degree
Location : Mumbai
Industry Type : Pharma / Biotech / Clinical Research
Last date : 14th August, 2016
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