job description
Join Erela, a leading innovator in the healthcare and medical sector, as a Senior R&D Formulation Specialist focused on Batch Record Optimization. This role is pivotal in ensuring the highest standards of product formulation, compliance, and efficiency in our research and development processes.
Based in the vibrant and dynamic environment of Denpasar, Bali, you will collaborate with cross-functional teams to refine and enhance batch records, driving continuous improvement in our formulation processes. Your expertise will directly contribute to the development of high-quality medical and health products that meet regulatory standards and exceed customer expectations.
This is a unique opportunity to work in a forward-thinking company that values innovation, precision, and excellence in the healthcare industry. If you are passionate about R&D, formulation science, and process optimization, we invite you to apply and be part of our mission to advance healthcare solutions.
Responsibility
- Develop, review, and optimize batch records to ensure accuracy, compliance, and efficiency in formulation processes.
- Propose and implement changes to batch records based on R&D findings, regulatory updates, and process improvements.
- Collaborate with QA/QC, production, and regulatory teams to align batch records with industry standards and company policies.
- Conduct risk assessments and validate changes to batch records to mitigate potential formulation or compliance risks.
- Maintain detailed documentation of all batch record modifications, including justifications, testing results, and approvals.
- Provide technical guidance to junior staff on batch record preparation, interpretation, and troubleshooting.
- Monitor and analyze batch performance data to identify trends and recommend process enhancements.
- Ensure all batch records adhere to GMP, ISO, and other relevant regulatory requirements for the healthcare and medical industry.
Qualifications
- Bachelor’s or Master’s degree in Pharmacy, Chemistry, Chemical Engineering, or a related field.
- Minimum 5 years of experience in R&D formulation, batch record management, or pharmaceutical production.
- In-depth knowledge of GMP, GLP, and regulatory guidelines for healthcare and medical products.
- Proven experience in batch record creation, revision, and validation in a regulated environment.
- Strong analytical and problem-solving skills with the ability to interpret complex formulation data.
- Excellent written and verbal communication skills in English for technical documentation and cross-functional collaboration.
- Proficiency in Microsoft Office, ERP systems, and formulation software (e.g., LIMS, SAP).
- Ability to work independently and in a team, with a detail-oriented and proactive approach to process improvement.