Lowongan Kerja Semarang Posisi Cmcd Manager di PT Bayer Indonesia

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

1. Brand Lead for Consumer Health Products
2. Manage CMCD Strategy for assigned brands for new product development (NPD) and lifecycle management (LCM) projects.
3. Author scientific briefing documents, complex TRDs, and responses to health authority questions; approve TRDs for NPDs
4. Conduct CMCD assessments for business due diligence projects.
5. Manage CMCD change impact assessments.
6. Author complex TRDs, and responses to health authority questions; approve TRDs for LCM projects.
7. Lead category continuous improvement initiatives.
8.  Provide coaching and training to colleagues.
9. Manage relevant functional processes.

QUALIFICATIONS

1. 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.
2.  High fluency in Chinese – Mandarin language. Able to write and review technical product specifications. 
3. Prior hands-on experience in a technical role within the pharmaceutical or related industry is preferred (Analytical Development, Formulation Development, Manufacturing).”
4. Strong understanding of product development processes.
5.  Knowledge/understanding of ICH. Knowledge of other quality systems guidelines is a plus.
6. Knowledge/understanding of USP, Ph.Eur. and other relevant Pharmacopoeias.
7. Familiarity with regulations, regulatory requirements and industry standards.
8. Strong understanding of cGMP, principles of Quality Assurance and equivalent.
9. Analytical and problem-solving abilities, with ability to prioritize and manage multiple projects simultaneously.
10. Good communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and stakeholders.
11. Proficient English communication skills, both written and verbal. 
12. Detail-oriented with the ability to maintain accurate documentation and records.
13. Ability to work independently and as part of a team in a fast-paced global environment.

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.