Pfizer ESQ Associate Vacancy – Pharmaceutical Science Job
Pfizer Vacancies – Pharmaceutical Vacancy. Pharma candidates are eligible to apply online for an Associate, ESQ vacancy at Pfizer. Pharma job opening 2020. Pharma job opening 2020. Check out all the details on our website Rasayanika.com
Job Title: Associate, ESQ
Location: India – Mumbai
Qualifications
- Min. BA/BS in Pharmaceutical Sciences or related technical discipline
- Min. 3 years of experience in GXP setting and/or Regulatory Affairs role
Advanced in computer skills such as MS Office applications and good knowledge of enterprise systems such as RCCM, PDM, QTS Trackwise, Documentum platforms, SAP - Good command of English language and multi-lingual is a benefit
- Strong verbal and written communication skills including presentation skills. Able to work in diverse multi-level, cross-divisional and multi-cultural working environment
- 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 initiative and proactive
Responsibilities
- Initiate, review and approve regulatory changes through the PDM for changes initiated by or impacting ESQ managed contractors.
- 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 the ESQ managed contractors.
- As the Regulatory Expert, participate in Virtual Site Operating Teams (VSOT) or similar meeting for ESQ managed contractors and if needed, participate in Site Quality visits at the contractors.
- Manage routine Customer Quality complaints for commercial Drug Products in CITI 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 for the confirmed complaints.
Role Description
- 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 Patients 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 complaints for the Drug Products and Drug Substances (APIs) manufactured globally.
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