QUALIFICATIONS:
Bachelor’s Degree in Pharmacy or any relevant science field.
EXPERIENCES:
Possess 4-5 years of experience in pharmaceutical research and development.
CHARACTERISTICS:
Meticulous person with good reasoning and communication and analytical skills.
JOB PURPOSE:
Responsible for new product development focusing on technology transfer products.
RESPONSIBILITIES:
1. Research and Development / New Product Development (NPD)
- Communicate with business partners regarding the technology transfer of new products.
- To prepare documents related to pilot batch (Batch Manufacturing Record, Batch Packing Record, Pilot Batch Protocol, Pilot Batch Report).
- To monitor execution of pilot batch in production area.
- To monitor execution of validation batch in production area as and when required.
- To manage and oversee the preparation of APPL samples for submission.
- To manage artwork development for blister foil, outer carton, and package insert using Adobe Illustrator (AI) software in-house or by working with external designer.
- To prepare variation documents required for variation submission with NPRA.
- To respond to correspondence from NPRA for formulation-related queries.
- To assist and train new joiner, protégé, and intern as required.
2. Compliance
- To ensure all processes and activities regarding research and development are in compliance with regulatory standards (e.g., GMP, GDPMD, GDP, ISO Standards).
- To ensure all documentation related to the Quality System is maintained at all times.
3. Other Key Responsibilities
- To participate in committee or any company activity appointed by the Site Director / committee leader.
- To undertake any other duties as directed by the Immediate Supervisor and Management as and when required.
- To provide technical support to other cross-functional departments such as Production, Quality Assurance, Quality Control and Regulatory Affairs.
- To prepare or revise relevant SOP.
Pay: RM4,000.00 - RM6,000.00 per month
Benefits:
- Additional leave
- Dental insurance
- Flexible schedule
- Free parking
- Health insurance
- Maternity leave
- Meal allowance
- Opportunities for promotion
- Professional development
- Vision insurance
Ability to commute/relocate:
- Rawang: Reliably commute or planning to relocate before starting work (Required)
Education:
Experience:
- Research and Development: 4 years (Required)
Work Location: In person