QA Manager - Pharmaceutical - Tambun - WFO (ID: 691128)

QA Manager - Pharmaceutical - Tambun - WFO (ID: 691128) Lead, manage, and develop the Quality Assurance (QA) team to ensure effective implementation of the company’s quality management system.

Ensure full compliance with applicable pharmaceutical regulations and quality standards, including CPOB, CPKB, CPPKRTB, Fasber, and ISO 9001.

Act as the Responsible Pharmacist for Finished Products (IF) and Pharmacovigilance Officer, including oversight of pharmacovigilance activities and regulatory obligations.

Oversee the preparation, implementation, review, and continuous improvement of SOPs, quality policies, and quality documentation.

Coordinate and collaborate closely with cross-functional departments such as Production, QC, R&D, Warehouse, Engineering, and Regulatory to ensure consistent product quality and compliance.

Manage quality risk assessments, deviations, CAPA, change control, complaints, and audit readiness (internal, external, and regulatory audits).

Support regulatory submissions and maintain readiness for SIPA registration in accordance with licensing requirements.

Develop and implement quality strategies aligned with business objectives and continuous improvement initiatives.

Provide effective communication and reporting in English and Indonesian to management and relevant stakeholders.

Utilize computer systems and quality tools efficiently for documentation, reporting, and data analysis.

Participate in and support CSR activities, both within and outside the city, as required by the company.

Qualifications

Licensed Pharmacist with a minimum GPA of 3.0

Holds a valid STRA and Serkom, ready for use in the SIPA registration process.

Minimum 3 years of experience as a QA Manager in a pharmaceutical company.

Accustomed to leading QA teams and collaborating cross-functionally with Production, QC, R&D, Warehouse, Engineering, and Regulatory departments.

Strong understanding of regulations and quality systems including CPOB, CPKB, CPPKRTB, Fasber, and ISO 9001.

Willing and capable of serving as Responsible Pharmacist for Finished Products (IF) and Pharmacovigilance Officer.

Willing to participate in CSR activities both within and outside the city.

Possesses strong strategic thinking and broad insight.

Proficient in computer operation.

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