External Manufacturing Quality Manager
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.
Education Requirements
Bachelor’s degree in pharmacist
Experience Requirements
Have a minimum of 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 managing external manufacturer audits, quality assessments, supplier qualification, and quality agreements.
Experience in pharmaceutical processing, technology, GMP, and Quality Management Systems (QMS).
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.
Strong communication skills
Have a good command of computers.
Employer questions
- Which of the following statements best describes your right to work in Indonesia?
- How many years' experience do you have as a Manufacturing Quality Manager?
- Which of the following types of qualifications do you have?
- Do you have a Bachelor Degree?
- How many years of experience do you have in the Pharmaceutical Industry?
Company profile
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).
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