Supply Operation Quality Assurance Specialist
Pfizer
This job is no longer accepting applications
See open jobs at Pfizer.See open jobs similar to "Supply Operation Quality Assurance Specialist" Greatness.bio.Why Patients Need You
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.
What You Will Achieve
The main responsibility of the Quality Assurance Specialist (contractor) is accountable to support the quality operation of UpJohn and Pfizer products at the Pfizer Country Office (PCO). The Quality Assurance Specialist serves as the liaison for Upjohn and Pfizer Indonesia as the point of contact for the investigation and resolution of all product quality issues discovered or originating in the PCO and for interacting with the relevant local stakeholders and local distributor on such issues.
The Quality Assurance Specialist will be accountable for the support of implementation and compliance to SOQ (Supply Operation Quality) Functional and Global SOPs and any other Pfizer Quality Standard requirements and the supply of compliant product into Indonesia market ensuring adherence to Good Manufacturing Practice for Medicinal Products
How You Will Achieve It
Product Complaint management
- Manages the intake of complaints from the PCO in a timely manner, tracks complaint responses.
- Develops and submit final responses (if required) related to investigation (to be provided to the complainant) for approval; respond to complainant in a timely manner.
Notification to Management
- Informs SOQ Manager and SOQ Lead of significant deviations and complaints as well as any issues impacting marketed product within the required timeframes.
- Support Quality Review teams to ensure cross-functional input into issues
- Support local market action team and ensure effective completion of all required actions i.e. recall.
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Product Quality System
- Support implementation of SOQ Functional and Global SOPs and any other Pfizer Quality Standard requirements.
- Manage Quality Systems such as Commitment Tracking and Change Control. Ensure timely completion of actions.
- Participate in risk assessment and apply Quality Risk Assessment tools as necessary.
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Local Product Disposition
- Performs local release of Upjohn and Pfizer products, in compliance with the applicable local regulations and local procedures, prior to sale within country. This includes temperature excursions resolution and compliance with registered details.
- Performs evaluation and disposition of returned stocks according to Pfizer Quality Standard requirements
- Ensure that Quarantine Alert Notices received are processed in a timely manner
- Perform risk assessment if required
Qualifications
Must-Have
- An Indonesia Registered Pharmacist, with valid Pharmacy Practice Certificate (STRA - Surat Tanda Registrasi Apoteker)
- Commercial Quality Experience in the pharmaceutical industry
- A minimum of 2 years in a quality role of pharmaceutical or medical device industry, with a minimum 1 year of experience as a Quality Officer or Specialist
- Knowledge of current Good Manufacturing Practice/ Good Distribution Practice
- Strong interpersonal skills; ability to communicate across all levels of the organization and also use communication to demonstrate the value of the quality organization
- Ability to interpret and analyze data with problem-solving skills
- Proficient in written and oral communication skills in English is a must
Work Location Assignment: Hybrid
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-PFEThis job is no longer accepting applications
See open jobs at Pfizer.See open jobs similar to "Supply Operation Quality Assurance Specialist" Greatness.bio.