1+ months

Quality Assurance Supervisor

Pfizer
Jakarta
Position Purpose:

The primary purpose of this position is to provide leadership and direction to Quality Assurance (QA) team.



The role will own the responsibility for evaluation and review of manufacturing operations and records, retained sample periodic review, SOP periodic review, QA quality performance metric; review of batch records prior to finished product disposition by QA Release Supervisor/QA Manager, batch record filing, validation report; prepare and review Manufacturing Investigation, Product Quality Review (PQR), product quality complaint investigation, notification to management, change control, Interim Report, CAPA, SOP and others GMP documents; management of stability program; maintaining QA master data in Enterprise One (E1), artwork & packaging material development, and non-inventory & packaging material specification, and Packaging Material complaint.



Ensure all processes in Quality Assurance (QA) are remain in compliant with site procedures and regulatory requirements, reliable and effectively performed, and ultimately that the team deliver on their commitments.

As QA Supervisor, keeping your team engaged, focused and aligned on key site priorities will be fundamental to your success.



Primary Duties:



+ Oversee overall manufacturing operations to ensure its compliance with the approved SOP, PQS, current GMP, and applicable regulatory requirements.

+ Coordinate and supervise daily activities of in-process control and packaging line inspection of the manufactured products.

+ Review and perform disposition of in-process manufactured product including sterilized materials, perform batch records review prior to finished product disposition by QA Release Supervisor/QA Manager,

+ Prepare and review Manufacturing Investigation, Product Quality Review (PQR), product quality complaint investigation, notification to management, change control, Interim Report, CAPA, PQS Compliance Analysis Status (CAS) Report, SOP and others GMP documents;

+ Manage stability program.

+ Coordinate and perform Artwork and Packaging material development.

+ Coordinate and supervise development and implementation of packaging material specification.

+ Maintaining QA master data in Enterprise One (E1); perform E1 quality implementation-review-part of ECO based on rejection of old item for new packaging material.

+ Coordinate and supervise daily activities of sampling and evaluation of packaging materials, imported products, non-inventory materials; perform disposition of packaging materials, incoming imported products, non-inventory materials, and semi-finished products; coordinate packaging material quality complaint completion with appropriate CAPA from supplier.

+ Manage and control that QA's SOP are in accordance with the actual practices, PQS, current GMP, and applicable regulatory requirements, consistently followed and implemented

+ Manage QA equipment & facilities in a clean, orderly and operational state, including calibration and verification status; perform retained sample periodic review, SOP periodic review, evaluate QA quality performance metric;

+ Coordinate management of batch record file, retention samples and stability samples filing and destruction activities as per approved SOP.

+ Drive team engagement and effective communication within QA team.

+ Actively coordinate with the teams to ensure the project (i.e., CIP, Operational Excellence, Innovation projects, etc.) in QA team are delivered in the most effective way.



Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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Posted: 2019-10-04 Expires: 2020-02-05

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Quality Assurance Supervisor

Pfizer
Jakarta

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