I. JOB SUMMARY
QA specialist is responsible for supporting the daily drug substance, drug product manufacturing and quality control operations internally and customer complaint handling. Functions include support of GMP documentation reviews, quality assessments and leading customer complaint investigation. Functions also include leading for resolving deviations, investigations, and out-of-specification issues.
II. JOB ACCOUNTABILITIES - List the primary accountabilities and supporting activities in order of importance.
%Time on this Accountability
Customer Complaint Handling
- Responsible for evaluating, documenting, and investigating product complaints including:
- Ensuring that complaint investigations are completed according to Site procedures and are consistent with PQS
- Informing the complaint triage function and documenting within the global complaint database any information made known after receipt of the complaint that impacts the complaint investigation (e.g., change of batch number or lot number, or a different product from that originally reported)
- Based on the country of origin of the complaints, notifying the appropriate affiliate or PQC of any complaints received directly at the Site
- Monitoring the timeliness of each investigation conducted
- Determining when analytical and/or physical testing of a product complaint sample is required
- Approving and closing the complaint investigation; and
- Maintaining all locally generated complaint records that are not attached to the global complaint database according to retention requirements
Assures compliance with regulatory requirements and Pfizer stands
- Performs all responsibilities in accordance with TFDA, related BoH drug and Pfizer stands for substance and Drug Product GMP regulations and associated guidelines.
- Reviews drug substance and drug product manufacturing batch records.
- Reviews process validation protocols and reports.
- Reviews IQ/OQ/PQ protocols and reports.
- Ensures the qualifications and validations are performed per the protocol.
- Leads the team and provides Quality guidance in the resolution of deviations, investigations, and out-of-specification issues (Root Cause, CAPA and Risk Evaluations).
- Has authority to approve or reject specifications, test methods, SOP’s, and protocols for PGS, Hsinchu plant.
- Has authority to approve or reject written procedures and other documents.
- Assists in updating GMP regulatory and quality documents.
- Participates in internal and external project team meetings
- Reviews SOPs and Quality Assurance procedures.
Assures that manufacturing process is run in accordance to approved product/process specifications
- Assures and participates in assuring that process deviations are properly investigation, documentation and corrective actions are implemented in accordance to the regulation of PICs GMP.
- Evaluates and gives disposition to Anomaly and Discrepancy Reports.
- Coordinates compliance review of manufacturing/packaging records to assure timely disposition of product.
First Time Quality
- Participates with Manufacturing and Technical Services personnel in resolution of product or process technical problems.
- Promotes activities within the PPU to improve quality levels.
- Recommends changes in procedures, equipment to improve product and process quality.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.