Indonesia Job Openings

Bayer

CMCD Manager (Mandarin Speaker)

Semarang

October 11, 2024


CMCD Manager (Mandarin Speaker)



The Chemical Manufacturing Control Documentation (CMCD) Manager - Mandarin Speaker supports the development of CMCD (Module 3 and Qo S) 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.


QUALIFICATIONS

  • 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 c GMP, 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.


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.





Application Period:
10/22/2024
Reference Code:
831091

Division:
Consumer Health
Location:
Indonesia : Central Java : Semarang || Indonesia : Central Java : Klaten

Functional Area:
Quality
Position Grade:
VS 1.1

Employment Type:
Regular
Work Time:
Standard Working Hours




Contact Us


Address
Telephone
E-Mail

ronwilfred.lee@bayer.com
New Job Alerts
PT Untung Bersama Sejahtera (UBS Gold)

Chemical Engineer

Surabaya

November 19, 2024

View Job Description
PT Untung Bersama Sejahtera (UBS Gold)

Data Analyst

Surabaya

November 19, 2024

View Job Description
PT Untung Bersama Sejahtera (UBS Gold)

Legal Staff

Surabaya

November 19, 2024

View Job Description
PT Sinar Global Solusindo

Teknisi GPS - Kelistrikan Kendaraan

Jakarta

November 19, 2024

View Job Description
PT Untung Bersama Sejahtera (UBS Gold)

Internal Audit

Surabaya

November 19, 2024

View Job Description
Looking for similar job?
Fortinet

Major Accounts Manager (Enterprise) - Indonesia

Jakarta

FULL TIME

August 30, 2024

View Job Description
CIMB Group

Network Sr EBB Relationship Manager - KC - LCB O622

FULL TIME

August 30, 2024

View Job Description
Marriott International, Inc

Asst Event Manager-Yogyakarta Marriott Hotel

Yogyakarta

August 31, 2024

View Job Description
Marriott International, Inc

Duty Manager - Yogyakarta Marriott Hotel

Yogyakarta

August 31, 2024

View Job Description
PT. Wisata Alam Sejati

Villa Manager

Denpasar

FULL TIME & CONTRACT

August 30, 2024

View Job Description
PT Lamonte Mode Internasional

Sales & Marketing Manager (Fashion Retail)

Depok

FULL TIME

August 30, 2024

View Job Description
See What’s New: Bayer Job Opportunities
Bayer

Head of Global Medical & Evidence Cardiovascular (all genders)

Basel

November 20, 2024

View Job Description
Bayer

Plant Engineer (all genders)

Muttenz

November 12, 2024

View Job Description
Bayer

Life Cycle Management Team Lead - Non Medicinal Products (all genders)

Basel

October 31, 2024

View Job Description
Bayer

Global Clinical Program Excellence Lead for Neglected Tropical Diseases (all genders)

Basel

October 29, 2024

View Job Description
Bayer

Medical & Evidence Lead (all genders)

Basel

October 22, 2024

View Job Description
View More Jobs by Bayer
New Job Alerts
PT Untung Bersama Sejahtera (UBS Gold)

Chemical Engineer

Surabaya

November 19, 2024

View Job Description
PT Untung Bersama Sejahtera (UBS Gold)

Data Analyst

Surabaya

November 19, 2024

View Job Description
PT Untung Bersama Sejahtera (UBS Gold)

Legal Staff

Surabaya

November 19, 2024

View Job Description
PT Sinar Global Solusindo

Teknisi GPS - Kelistrikan Kendaraan

Jakarta

November 19, 2024

View Job Description
PT Untung Bersama Sejahtera (UBS Gold)

Internal Audit

Surabaya

November 19, 2024

View Job Description