Hiring company: Pfizer
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 Senior Associate will be responsible for supporting Contractor Quality Leads and Team Leads in activities associated with the oversight of contract manufacturers who manufacture products for Pfizer.
Responsibilities:
The Senior Associate will be responsible for activities that support contract manufacturer oversight and product compliance, including but not limited to:
- Review and summarize Annual Product Review and Product Quality Review (APR/PQR) reports, notify the Contractor Quality Leads (CQLs) of any issues, and provide the summary for approval.
- Conduct Quality oversight for low-risk contract manufacturers.
- Take a lead in change control monitoring and oversight for ESQ teams. Monitor and support on open change controls coming due, identify change controls stalled or held. Request extension or closure of change controls in QTS.
- Lead and Project Manage compliance and continuous improvement initiatives and projects.
- Manage quality activities to support QP declaration issuance as per standard work, Dossiers Gap Assessments to support product compliance. Perform Compendial Update assessments.
- Support and execute tasks in the Quality Tracking System (QTS) and Supplier Management System (SMS) in support of product and contractor oversight.
- Review and track intercompany complaints, product temperature excursions, and routine relabelling/repackaging activities. Support product compliance related activities to allow proper supply, e.g. batch Certificate of Analysis related requests.
- Support team in management of QTS commitments, complaints, etc. within quality systems as necessary.
- Provide support in management and presentations of team KPI metrics.
- Participate and support risk assessments related to contractors / products as necessary.
Qualifications:
- Minimum. University degree in Science, Engineering, Pharmaceutical Sciences or similar.
- At least 5 years of Product Quality Assurance experience in a GMP environment.
- Asepticmanufacturingexperiencewouldbe an asset.
- Experience with external suppliers/contractors is preferred.
- Advanced in computer skills such as MS Office applications and good knowledge of enterprise systems such as SAP, 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 diverse multi-level, cross-divisional, and multi-cultural global working environment.
- Able to report remotely and deliver work independently.
- Show strong negotiation skills and customer focus.
- 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 be proactive.
- Actively participate in Team Meetings by reporting activities, achievements and lessons learned.
PLEASE SUBMIT YOUR CV IN ENGLISH
LAST DAY TO APPLY: November 18th
Purpose - Breakthroughs that change patients' lives...
At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
Pfizer colleagues in different countries work together to improve the health of people all over the world. We are constantly working on the development of innovative therapies and growth opportunities, being in continuous search of new talents.
Flexible Work Environment
We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!
Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.