Supervisor Quality Control

About us:
We are PT. Amarox Pharma Global, a subsidiary of HETERO - one of the world’s leading producers of Active Pharmaceutical Ingredients (APIs) and generic formulations, with an active presence across 145+ countries and backed by 30 years of experience in the pharma sector.

Job Purpose:
As a Quality Control Supervisor at PT Amarox Pharma Global, you will oversee daily lab operations, ensuring compliance with regulatory standards. Your role will involve supervising method validation, sample analysis, SOP management, training staff, and ensuring adherence to GLP, GDP, and GMP.

Key Responsibilities:

Method Validation and Verification:
Ensure all methods used for analysis are validated and verified in accordance with industry standards. Review and approve validation protocols and reports to confirm method suitability and reliability.

Sample Analysis Oversight:
Supervise and guide QC analysts in performing sample analysis to ensure accuracy and consistency with established methods and protocols. Maintain strict adherence to quality and regulatory standards during all testing procedures.

Resource Management:
Ensure reagents, materials, tools, and instruments are fit for use and within calibration range. Collaborate with procurement to ensure timely replacement of laboratory supplies.

SOP Management and Staff Training:
Update and maintain Standard Operating Procedures (SOPs) for the QC department. Conduct training sessions for QC staff and other departments on SOP updates, best practices, and quality control procedures.

Compliance Support:
Assist in the implementation of Good Laboratory Practices (GLP) in the laboratory. Ensure compliance with Good Documentation Practices (GDP) to maintain data integrity and traceability.

Reporting:
Compile, manage, and present analytical development reports to the manager. Provide insights and recommendations to support informed decision-making.

Quality Assurance Support:
Contribute to the implementation and maintenance of GMP (Good Manufacturing Practices) across all QC operations. Ensure lab equipment and facilities meet GMP compliance standards.

Requirements:

Education: Bachelor's degree in pharmacy (mandatory).

Experience: At least 5 years of experience in a quality control laboratory, with at least 2 years in a supervisory role. Experience in an oncology site is a plus.

Skills:
Strong knowledge of analytical techniques and instrumentation.
Excellent leadership and team management abilities.
Proficiency in updating SOPs and conducting training.
Strong communication and reporting skills.
Familiarity with GLP, GDP, and GMP regulations.

Personal Attributes:
Strong attention to detail and commitment to continuous improvement.
Ability to stay updated with industry standards and regulations.