Head Of Quality Operation

Pt Taisho Pharmaceutical Indonesia; Depok; On-site; IDR 1,200,000,000 - 1,800,000,000; Full time

Job summary

PT Taisho Pharmaceutical Indonesia seeks a Head of Quality Operation to lead, manage, and coordinate Quality Operations, driving improvements while ensuring compliance with cGMP and regulatory standards. The role focuses on Quality Assurance, Quality Control, and Validation, with a strategic plan to meet quality, cost, and target objectives.

Responsibilities include overseeing product quality release, regulatory compliance, complaints, recalls, and continuous improvement initiatives across

Qualifications

• Bachelor’s degree in Pharmacy with a Professional Pharmacist Degree (Apoteker).
• Minimum 12 years of experience leading and managing the Quality Department in the pharmaceutical industry.
• Experience in EU-GMP implementation.
• Knowledge of updated regulations and cGMP requirements.
• Experience in physical and chemical analysis, equipment, and inventory management systems.
• Strong analytical thinking and problem solving.
• Strong business acumen.
• Good command of computers.

Responsibilities

• Lead and oversee Quality functions, including Quality Assurance, Quality Control, and Validation, ensuring compliance with regulations and company standards.
• Develop and implement quality strategies, systems, and continuous improvement initiatives.
• Oversee product quality release, regulatory compliance, product complaints, and recalls.
• Coordinate with cross-functional teams to maintain quality standards throughout manufacturing and operations.
• Lead, develop, and strengthen the Quality team through coaching and performance management.

Skills

Analytical thinking

Problem solving

Computer literacy

Education

Bachelor’s degree in Pharmacy with a Professional Pharmacist Degree (Apoteker)

Job description

Head of Quality Operation

Lead, manage, and coordinate Quality Operations matters by providing a strategic plan to maintain compliance and drive improvements in accordance with procedures and policies, meeting Quality, Target, and Cost objectives.

Accountability

Lead and oversee Quality functions, including Quality Assurance, Quality Control, and Validation, ensuring compliance with applicable regulations, cGMP, GLP, and company standards.

Develop and implement quality strategies, systems, and continuous improvement initiatives to maintain product quality and operational excellence.

Ensure effective implementation of quality systems, including change control, CAPA, deviation management, calibration, supplier quality management, and product quality review.

Oversee product quality release, regulatory compliance, product complaints, and product recall activities.

Collaborate with cross-functional teams to ensure quality standards are consistently maintained throughout manufacturing and operational processes.

Lead, develop, and strengthen the Quality team through coaching, performance management, and competency development.

Requirement

Bachelor’s degree in Pharmacy with a Professional Pharmacist Degree (Apoteker)

Have a minimum of 12 years of experience leading and managing the Quality Department in the pharmaceutical industry.

Have experience in EU-GMP implementation.

Have good knowledge of updated regulations and cGMP requirements.

Experience in physical and chemical analysis, equipment, and inventory management systems.

Have strong analytical thinking and problem-solving.

Have strong business acumen

Have a good command of computers.

Pharmaceuticals, Biotechnology & Medical Devices 101-1,000 employees

Taisho Pharmaceutical Indonesia is the subsidiary of Taisho Pharmaceutical Co., Ltd., Japan - the number one over-the-counter medications company in Japan.

In Indonesia, Taisho Pharmaceutical has been operating since the end of 2009 after acquiring Bristol-Myers Squibb. Our main brands are Counterpain, Tempra, Theragran-M, Kenacort, Myco-Z and Mycostatin OS (Oral Suspension).