QA & Qc Lab Ops Lead

3 months ago

Jakarta, Indonesia Nusantics Full time

Responsible for managing QA/QC/laboratory activities and ensuring these activities run smoothly and efficiently.

Ensuring the established guideline and procedure has been understood, followed, and implemented properly by all team members.

Monitoring all activities related to repair, maintenance, and calibration of all equipment conducted as per stated procedure, Ensuring that all equipment used in the company (laboratory and production area) runs well as per the specification of the equipment.

Handling any customer complaints or queries as necessary and wisely

Lead the investigation process and work closely with other Lead Departments for any problems that arise related to customer complaints, discrepancies during the analysis and reporting process, as well as incidents that occur.

Support the activity related to all Environment, Occupational Health, and Safety (EHS) programs and requirements, especially in the laboratory, production and warehouse, where biological agents of concern are used, handled, or stored.

Conduct training and assessment related to quality and safety, especially to QA/QC/Lab members and Technical Team (Operations and R&D Team)

Support in the training of new staff on workflow and guideline/procedure/working instruction etc.

Assist in the supervision of staff and promote teamwork, deals with any staff issues which may arise from time to time i.e. grievances, disciplinary matters, and others.

Assist in the administrative matters as and when required and ensure all documents are systematically filed.

Create weekly and monthly performance reports for technical operation activities.

Conducting the procedure related to IQA/Internal Quality Assurance (PMI/Pemantapan Mutu Internal and EQA/External Quality Assurance (PME/Pemantapan Mutu Eksternal) follows the established procedure and complies with the government regulation.

Responsible for other assignment tasks as appointed by the company.

Responsible as a management representative and Penanggung Jawab Mutu for the implementation of the Internal Quality Assurance System which is integrated with CPAKB and the ISO 13485 (Quality Management System for Medical Devices).
Passionate in preserving Indonesia biodiversity through sustainable innovations.

Bachelor of Science in Biology, Biomedical Science/Engineering, Pharmaceuticals, Chemistry, Chemical/Industrial Engineering or other related major.

Having at least 5 years of working experience in QA/QC and laboratory, with at least 3 years of experience as a supervisor, having experience in managerial position is an added value.

Having experience in GMP, GLP, ISO 9001, and ISO 17025 is a must.

Having experience in CPAKB, and ISO 13485 is an added value.

Good computer skills, i.e. experience in Google Workspace (Sheet, Slides & Docs) or MS Office (Excel, Word and PPT).

Have high integrity, honesty, dynamic, highly organized, and excellent attention to detail.

Able to work with a team, excellent communication, interpersonal skills, problem solving, and leadership. Able to manage complex and large teams.

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