**Responsibilities**:
- Principle Objective of Position Ensure the implementation of registered document in plant accordance with Health Authority and Organon (OMS) requirement. Coordinate with market RA for handling regulatory documentation in Pandaan plant.
- Major Duties/ ResponsibilitiesReview and approve Bill of Material (BOM), Artwork, Revision Level, Item Description and document related.
- Collaborate with market RA for required documentation for submission to market Health Authority
- Coordinate with Pandaan team for documentation preparation and review for submission to market Health Authority
- Ensure implementation of Health Authority Reporting met regulatory and OMS policy.
- Responsible to keep abreast site safety & quality requirement and specific compliance policy and standards at daily work.
- Demonstrate quality leadership behavior, promotes a quality culture, and proactively supports cGMP compliance.
- Promote the site SHE culture, including but not limited to, the interdependency safety culture.
**Qualification**:
- Diploma is acceptable, and Degree is preferable.
- Sound understanding of Indonesian and ASEAN Countries regulatory requirements for pharmaceutical industries, GMP. GLP, and GDP
- Conceptual and systematic, meticulous, good leadership, excellent writing and communication skills.
**Secondary Job Description**
**Who We Are**:
Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women's Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.
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**Annualized Salary Range**
**Annualized Salary Range (Global)**
**Employee Status**:
Temporary (Fixed Term)
**Relocation**:
Domestic
**VISA Sponsorship**:
**Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites**
**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Number of Openings**:
1
**Requisition ID**:R522253