External Manufacturing Quality Manager

PT Taisho Pharmaceutical Indonesia Tbk.; Depok; On-site; IDR 446,400,000 - 781,200,000; Full time

Job summary

Taisho Pharmaceutical Indonesia Tbk. is seeking an External Manufacturing Quality Manager to oversee quality activities for external manufacturing and OEM partners.

The role ensures compliance with product specifications, quality standards, and regulatory requirements throughout the product lifecycle. The ideal candidate has at least 10 years of pharmacist experience in the pharmaceutical industry, with expertise in GMP, process transfer, and packaging development.

Qualifications

• Pharmacist with at least 10 years of experience in the pharmaceutical industry.
• Experience in process transfer and manufacturing technology.
• Experience in product development and packaging development.
• Experience in pharmaceutical processing, technology, and GMP.
• Experience handling other product categories such as food, medical devices, and related categories.
• Strong understanding of GMP and related regulations.
• Excellent communication skills and computer literacy.

Responsibilities

• Oversee quality of products manufactured by external partners to ensure compliance with product specifications and GMP.
• Oversee quality assessments, partner performance, and quality activities throughout the product lifecycle.
• Support Business Development and New Product Development with quality input for toll manufacturing and rebranding.
• Collaborate with internal teams and external manufacturers to execute quality-related activities.
• Establish and monitor quality requirements for external manufacturers.
• Participate in quality risk assessments and oversee site quality aspects.

Skills

Pharmacist

GMP knowledge

Communication skills

Computer literacy

Education

Bachelor of Pharmacy

Job description

External Manufacturing Quality Manager

Oversee quality activities for external manufacturing and OEM partners, ensuring compliance with quality standards and company requirements. Manage quality assessments, partner performance, and quality activities throughout the product lifecycle to ensure product quality and business continuity.

Accountabilities

Oversee the quality of products manufactured by external partners to ensure compliance with product specifications, quality standards, and regulatory requirements throughout the product lifecycle.

Support Business Development and New Product Development (NPD) projects by providing quality and technical input for toll manufacturing and rebranding products.

Collaborate and coordinate with internal teams and external manufacturing partners to ensure effective execution of quality-related activities.

Establish and monitor quality requirements for external manufacturers to ensure alignment with company quality standards and their effective implementation.

Participate in quality risk assessment activities and oversee operational quality aspects related to external manufacturing sites.

Ensure appropriate Quality Agreements are established, incorporated into relevant contracts, and maintained in accordance with applicable standards and requirements.

Provide quality management support and perform other quality-related activities as assigned by the Head of Quality Operations.

Support the implementation and maintenance of the Halal Product Assurance System at external manufacturing sites in accordance with applicable requirements.

Experience Requirements

Have a minimum 10 years’ experience as a pharmacist in the pharmaceutical industry

Experience in process transfer and manufacturing technology

Experience in product development and packaging development

Experience in pharmaceutical processing, technology, and GMP

Experience handling other product categories such as food, medical devices, and related categories.

Have a good understanding of GMP and the regulations and requirements of the related product category.

Have good communication skills

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).

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).