Associate, ESQ

Associate, ESQ

Pfizer Asia Pacific Pte Ltd
Philippines
3-6 years
Not Specified

Job Description


Job Description :
  • 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 complaintsfor the Drug Products and Drug Substances (APIs) manufactured globally.
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.
Qualifications
  • Min. BA/BS in Science, Engineering, 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

#LI-PFE
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.Quality Assurance and Control#LI-PFE

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Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.

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