Pfizer Site Quality System Manager in Jakarta, Indonesia
Role summary :
Accountable for quality oversight of activities involved in developing and maintaining quality programs, processes and procedures at site level that ensure compliance with Pfizer Quality Standards, cGMP, applicable regulatory requirements and ISO 9001 standards. Provides expertise and guidance in interpreting Pfizer Quality Standards, cGMP, regulatory and/or governmental regulations to assure compliance and provides oversight on GMP training management and document lifecycle management at site level, ensures the quality assurance programs and policies are maintained and updated regularly. L eads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits. Provides oversight on the Supplier Quality management, conduct audit to supplier/contractor and support supplier/contractor development
Roles and Responsibilities :
Ensure the compliance of Quality Management System with Pfizer Quality Standards, current GMP, regulatory requirements, and ISO 9001 by: - Coordinating the implementation of Pfizer Quality Standards (Quality, Facility & Equipment, Materials, Production, Packaging, Laboratory, and Validation) in the manufacturing operation. - Coordinate gap analysis against Pfizer Quality Standards, cGMP, applicable regulatory requirements, and ISO 9001 and ensure the action required to close the gap is completed. - Preparing and maintaining procedures for the quality system in accordance with the Pfizer Quality Standards, applicable current GMP regulations, and ISO 9001.
Oversight PGS Jakarta internal audit management system by : - Establishing internal audit program based on applicable regulatory requirements, Pfizer policies and procedures, ISO standards and criticality of the operations using Quality risk management approach - Ensure execution of internal audit program - Qualification of internal audit team - Reviewing, approving and tracking completion of action items
Oversight PGS Jakarta documentation system throughout document life cycle based on applicable regulatory requirements, Pfizer policies and procedures, data integrity requirements, ISO standards
Prepare registration variation package for Regulatory submission by working closely with cross function team
Oversight PGS Jakarta training management by : - Working together with PGS Jakarta expertise to develop training material and oversight the training implementation - Coordinate and arrange Global Training for PGS Jakarta learner - Provide monthly % training completion report and coordinate to update the training records of PGS Jakarta learner and other training related data in PGS Learning Solution (PLS) System - Provide the periodic notification to S-QRT on the PGS Jakarta training completion achievement
Working together with QA Manager performed Annual Product Review by: - Ensure that required data are assembled - Provide the summary of APR including finding and conclusion - Ensure that the APR are completed and approved - Provide the periodic notification to S-QRT on the completion of APR recommendation
Manage CAPA derived from Annual Product Review, CAS Report PQS, internal and external audit observations through commitment tracking in gQTS
Act as PGS Jakarta Site Compliance Lead in leading audit and inspection through all stages of the audit and inspection, starting from preparation until resolution of audit and inspection findings by working closely with cross function team in PGS Jakarta site
Working together with Purchasing Department on supplier quality management system for the following activities : - Maintaining supplier/ contractor qualification and database - Supplier & contractor Audit
Issue supplier & contractor audit prioritization and schedules
Ensure the execution of supplier&contractor audit program and reports completion
Periodically review the list of Jakarta approved supplier&contractor
Follow up on any supplier&contractor audit action item/ findings until actions associated with findings are completed - Support for supplier & contractor Development - Preparing/reviewing draft of quality agreement and ensure that the quality agreement is followed by both parties.
Preparing monthly summary of quality metric and present in the SQRT meeting and act as additional SQRT team member
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.