We are seeking a dedicated and result-oriented Formulation Officer to join our Technical Service team. In this role, you will be responsible for leading product transfer projects including process design, optimizing existing products and processes, evaluating alternative sources, and providing technical support for commercial products in strict compliance with GMP (CPOB/CPOBAB), safety standards (EHS), and internal SOPs.
Responsibilities
Responsibilities
- Project Execution & Management: Plan, execute, and monitor product transfer in terms of technical aspect, process improvement, and alternative source projects within established timelines.
- Commercial Product & Validation Support: Provide hands-on technical support for commercial products, including production troubleshooting, and designing manufacturing recipes for validation and commercial purposes.
- Technical Documentation: Prepare and compile comprehensive technical documentation, formulas, manufacturing instructions (for trial and 1st commercial validation), and trial evaluation reports for registration purposes and commercial rollout.
- Trial & Process Evaluation: Oversee formulation and process trials, evaluate material requirements, and recommend optimized formulations and processes to stakeholders.
- Cross-Functional Collaboration: Coordinate actively with internal stakeholders (Production, internal TS, Quality Compliance, Quality Control, Quality-Validation, Engineering, and EHS) to ensure smooth project execution.
- Continuous Improvement & Audits: Actively participate in internal/external audits, CAPA execution, risk management, and process/procedural improvements.
- Safety & Compliance: Ensure strict adherence to EHS standards during trials to maintain a safe, zero-accident environment.
Qualifications
Qualification & Requirement
- Education: Minimum Bachelor’s Degree (S1) in Pharmacy; Registered Pharmacist (Apothecary) qualification is strongly preferred.
- Experience: Minimum 2-3 years of hands-on experience in Production area, Technical Projects, or Technical Service within the pharmaceutical industry.
- Technical Expertise: Good understanding of Good Manufacturing Practice (CPOB/CPOBAB), Good Distribution Practice (GDP), formulation development, manufacturing process design, data integrity, and risk management.
- Language Proficiency: Active in both Indonesian and English (written and verbal).
- Core Competencies: Strong analytical, problem-solving, project management, and cross-functional communication skills.
- Physical Requirements: Normal color vision (non-color blind) and no history of drug allergies.
