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Position: Senior Associate, SCESQ (Quality Assurance & Control
Location: Mumbai, Maharashtra
- Our Global Quality Operations Mission is “to be a proactive partner, driving a science and risk-based compliant quality culture that is flexible, innovative, and customer-oriented, maximizing the contribution of Quality Operations to Our Path Forward initiatives.”
- External Supply Quality (ESQ) drives excellence in Quality by maximizing our Partner collaboration to ensure the Patient’s confidence in our Products.
- ESQ is responsible for the Quality management of approximately 400 contract manufacturers, packagers, and supply partners globally.
- The person will be responsible for regulatory change management activities as a Site Compliance Network Member (SCNM) and management of routine product complaints about the Drug Products and Drug Substances (APIs) manufactured by Contract manufacturers.
- Initiate, review, and approve regulatory changes through PDM for changes initiated by or impacting ESQ managed Contract manufacturers.
- Provide support for the closure of the deficiency letters and CMC Commitments, Regulatory requests for Renewals, New Product registrations, and Post-approval variations.
- Serve as the main point of contact for the Global Chemistry, Manufacturing and Controls (GCMC) department or Local Regulatory Affairs in the Pfizer Country Offices (for Single market products) for the various regulatory activities involving ESQ managed Contract manufacturers.
- As the Regulatory Compliance and Product Complaint Expert, participate in Virtual Site Operating Teams (VSOT) (or similar) meetings for ES/ESQ managed Contract manufacturers and if needed, participate in Site Quality visits at the Contract manufacturers.
- Manage routine Customer Quality complaints about commercial Drug Products in PCOM and work in collaboration with the ESQ Contractor Quality Lead for ensuring that the investigation reports are appropriate and acceptable. Ensure timely closure of complaints and alerting the appropriate colleagues as per our procedure and Standard Work guidance.
- Support and Perform Lot Disposition for Biotech products in collaboration with other functions.
Desired Skills & Competencies:
- Advanced in computer skills such as MS Office applications and good knowledge of enterprise systems such as PDM, QTS Trackwise, Documentum platforms
- Good command of English language and multi-lingual is a benefit
- Strong verbal and written communication skills including presentation skills. Able to work in the diverse multi-level, cross-divisional and multi-cultural working environment
- Able to report remotely and deliver work independently
- Show strong negotiation skills and customer focus
- Is diplomatic in communication with internal and external customers
- Demonstrate ability to prioritize work, manage multiple projects, act and work independently and to report items as required to Team Leader
- Take the initiative and be proactive
Qualification: BA/BS in Science/Engineering/Pharmaceutical Science or Equivalent
Experience: Min. 5 years of experience in GXP setting and/or Regulatory Affairs role (or 3 years with Masters degree)
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