Specialist, Operations

**The Position**

Responsible for to produce high-quality, standardized, and efficient products in line with PT Organon Pharma Indonesia Tbk’s regulations. This position is also responsible for ensuring compliance and improving the drug manufacturing process, as well as the packaging process to create a finished product that is market-ready in accordance with established standards, both in terms of GMP and safety.

**Major Duties/ Responsibilities**
- Reviewing and providing input on drug manufacturing processes, from manufacturing to packaging, to finished product, includes reviewing batch records.
- Leading the Tier 1 production process in the absence of the operation supervisor.
- Participating as a member of the Plant Inspection Team, investigating issues that impact product quality as needed.
- Involved in the improvement process to analyze production capacity, cost, and efficiency perspectives.
- Responsible for manufacturing and packaging electronic batch record maintenance, including creation of article, work center, route, and recipe.
- Supporting the implementation of projects related to technology transfer.
- Supporting Change Control for Equipment and Processes from a Compliance and Improvement Process perspective.
- Assisting in the allocation of resources for the production process and continuous improvement.
- Responsible for implementing Preventive Action and Corrective Action related to Continuous Improvement Initiatives.
- Managing monthly metrics for continuous improvement and GMP compliance.
- Supporting daily GEMBA at IPT organization and other IPS meetings, whether daily, weekly, or monthly.
- 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.
- Perform chapter QMS and/or SHE if assigned.

**Preferred Education, Experience, and Skills**
- Pharmacist or bachelor degree of pharmacy is preferable
- This position requires knowledge of quality / compliance management as well as regulations and standards affecting Pharmaceutical products
- 1 or 2 years of experience in a professional or pharmacy setting
- Experience in SAP are preferred
- Ability to quickly know products and processes in order to assess Operation problem and Quality impacts issue
- Understand GxP requirements and regulations (CPOB, PICs, etc)
- Good communication skills both verbal and written
- English proficiency required
- Good interpersonal skill
- Good planning and scheduling skills
- Have willingness to learn more about production process and improvement
- Having high patience in reviewing document (Batch record, datasheet, etc)
- Ability to work independently, prioritize tasks, and meets deadlines

**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.

**Search Firm Representatives Please Read Carefully**

**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**:
Regular

**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**:R525717