Plant Regulatory Specialist

Job Description

The 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.

Responsibilities

• Review 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.

• Any other task assigned by Quality Compliance Lead

Required Education, Experience and Skills

• A degree in Pharmacy is preferred; a degree in Chemistry or Chemical Engineering is also acceptable.
• Fresh graduates or candidates with up to 2 years of relevant experience are welcome to apply.
• Sound understanding of Indonesian and ASEAN pharmaceutical regulatory requirements, as well as GMP, GLP, and GDP standards.
• Strong conceptual and systematic thinking skills, with meticulous attention to detail, leadership potential, and excellent written and verbal communication skills.
• Native-level proficiency in Indonesian and strong written and spoken English 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.

As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants. 

Search Firm Representatives Please Read Carefully 
Organon LLC, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Annualized Salary Range

Annualized Salary Range (Global)

Annualized Salary Range (Canada)

Please Note: Pay ranges are specific to local market and therefore vary from country to country.

Employee Status:

Temporary (Fixed Term)

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites

No Travel Required

Flexible Work Arrangements:

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

Number of Openings:

1