CMCD Manager (Mandarin Speaker)
myGwork - LGBTQ+ Business Community
Tanggal: 4 hari yang lalu
Kota: Semarang, Central Java
Jenis kontrak: Penuh waktu
This job is with Bayer UK & Ireland, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.
[[title]]
The Chemical Manufacturing Control Documentation (CMCD) Manager - Mandarin Speaker supports the development of CMCD (Module 3 and QoS) strategy for Bayer’s Consumer Health new and existing product pipeline and has life-time responsibility for all Bayer Consumer Health CMC Documentation
MAJOR TASKS
Application Period: 10/22/2024 Reference Code: [[id]] Division: [[filter1]] Location: West Java, Cisalak Functional Area: [[filter6]] Position Grade: [[cust_subgrade]] Employment Type: [[filter7]] Work Time: Standard Working Hours Contact Us Address Telephone E-Mail [email protected]
[[title]]
The Chemical Manufacturing Control Documentation (CMCD) Manager - Mandarin Speaker supports the development of CMCD (Module 3 and QoS) strategy for Bayer’s Consumer Health new and existing product pipeline and has life-time responsibility for all Bayer Consumer Health CMC Documentation
MAJOR TASKS
- Brand Lead for Consumer Health Products
- Manage CMCD Strategy for assigned brands for new product development (NPD) and lifecycle management (LCM) projects.
- Author scientific briefing documents, complex TRDs, and responses to health authority questions; approve TRDs for NPDs
- Conduct CMCD assessments for business due diligence projects.
- Manage CMCD change impact assessments.
- Author complex TRDs, and responses to health authority questions; approve TRDs for LCM projects.
- Lead category continuous improvement initiatives.
- Provide coaching and training to colleagues.
- Manage relevant functional processes.
- Bachelor's degree in a relevant scientific field (e.g., Chemistry, Biochemistry, Biotechnology), or international equivalent, with +6 years of prior hands-on experience in a technical role within the pharmaceutical or related industry (Analytical Development, Formulation Development, Manufacturing). Master’s degree or higher, in a relevant scientific field (e.g., Chemistry, Biochemistry, Biotechnology), or international equivalent, with +4 years of proven hands-on experience (Analytical Development, Formulation Development, Manufacturing). Ph.D. degree, in a relevant scientific field (e.g., Chemistry, Biochemistry, Biotechnology), or international equivalent.
- High fluency in Chinese - Mandarin language. Able to write and review technical product specifications.
- Prior hands-on experience in a technical role within the pharmaceutical or related industry is preferred (Analytical Development, Formulation Development, Manufacturing)."
- Strong understanding of product development processes.
- Knowledge/understanding of ICH. Knowledge of other quality systems guidelines is a plus.
- Knowledge/understanding of USP, Ph.Eur. and other relevant Pharmacopoeias.
- Familiarity with regulations, regulatory requirements and industry standards.
- Strong understanding of cGMP, principles of Quality Assurance and equivalent.
- Analytical and problem-solving abilities, with ability to prioritize and manage multiple projects simultaneously.
- Good communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and stakeholders.
- Proficient English communication skills, both written and verbal.
- Detail-oriented with the ability to maintain accurate documentation and records.
- Ability to work independently and as part of a team in a fast-paced global environment.
Application Period: 10/22/2024 Reference Code: [[id]] Division: [[filter1]] Location: West Java, Cisalak Functional Area: [[filter6]] Position Grade: [[cust_subgrade]] Employment Type: [[filter7]] Work Time: Standard Working Hours Contact Us Address Telephone E-Mail [email protected]
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