Senior Associate I-Quality Management System (QMS)Coordinator

Company Overview 
Zoetis is a global animal health company dedicated to supporting customers and their businesses. With more than 60 years of experience, we deliver quality medicines, biopharmaceuticals, vaccines, diagnostic products, and genetic tests, complemented by a range of services. We are committed to addressing the real-world challenges faced by those who raise and care for animals. 

Position Summary 

The Quality Management System (QMS) Documentation Coordinator will provide support to quality compliance and training documentation related VMRD activities with focus on VMRD Thane operations. This position will be responsible to maintain documentation in line with the QMS including review and maintenance of documents as per various health authority requirements and as per expectations and compliance to respective company policies and procedures. This role will support SOP and guideline management, training documentation and management of the documentation cell. This is an individual contributor role with no supervisory responsibility. 

Key Responsibilities 
    Tracking, follow up, archival and retrieval of documents, online entries in global documentation tracking software, laboratory notebook management for Thane site, upload site/ product related documents in global document repository. 
    Coordination with internal partners/ global teams for documentation management. 
    Tracking, follow up for SOPs/ guidelines and format (form) management as SOP management coordinator. Support initiatives to bring alignment between VMRD SOP/ guideline and global quality system procedure. 
    Responsible for administration of manual / paper-based QMS documentation like change control, deviation, incident, OOS/OOT etc. on routine basis and maintain track records required by SOPs. Preparation of QMS trending. 
    Act as GMP/product development related training coordinator for VMRD Thane site. Responsible for coordination, preparation, maintaining and tracking training curricula, training records and their compliance status. 
    Maintains a centralized tracker for CRO qualification documentation, including effective/expiry dates, quality agreements, quality audit reports, etc. Sends scheduled reminders and communicates status changes to QA, Procurement, and functional SMEs; escalates overdue actions per governance thresholds. 
    Internal VMRD Thane audit compliance follow up, scheduling and coordinate in self inspections, quality audits etc. 
    Supporting CoDev / RegCMC teams, provide documentation support as needed for regulatory CMC filing. 
    Coordinate for creation of job descriptions/ curriculum vitae of colleagues/ contract colleagues as per guidance provided by global quality compliance team. 
    As appropriate, provide documentation support to cross functional teams at VMRD Thane and across global teams. 

Qualifications 
    Master or Bachelor's Degree or equivalent in Life Sciences, Chemistry, Pharmacy and Engineering with 8-10 years relevant experience in Quality Assurance documentation, training management having basic computer operating knowledge, preferably worked in Good Manufacturing Practices (GMP) environment. 

Essential Skills & Competencies: 
    Self Motivated individual with good communication, well versed with Quality Management System. 
    Ability to work in interdisciplinary and/or cross-cultural teams. 
    Candidate must be able to quickly adapt to changing work scenarios. 
    Thorough understanding of documentation related activities and processes in pharmaceutical industry. 
    Good time management, trouble shooting and decision-making skills. 

 

 

Full time

 

 

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