Duopharma Biotech Bhd Group of Companies. is looking for new potential candidates to fill in for SENIOR EXECUTIVE, FORMULATION & R&D TECHNOLOGIES (BASED IN GLENMARIE) position. If you currently looking for new healthcare job opportunities and qualified with the job desc, feel free to apply this job.
- Responsible to execute formulation and manufacturing processes development for in-house developed products; to support the product registration with pilot batches manufacturing, studies and documentation in compliance with regulatory; and the quality system for technology transfer.
- Follow procedures in managing procedures and records of laboratory and department for scheduled poison and waste; equipment and machines, internal processes, etc.
- Ensure inventory under pharmacy license is well recorded and ready for inspection.
- Evaluate and approve new ingredient as per agreed timelines.
- Plan and conduct pre-formulation study according to procedures including literature search; excipients and APIs evaluation, incompatibility studies; reference product characterization etc.
- Plan and perform formulation design and development with trials, with Quality by Design concept; focusing in ethical product and problematic products
- Plan the pilot batches and process validation batches with manufacturing sites including material planning and tooling.
- Plan and prepare for pilot batch by preparing protocol, execution, collecting sample and then report according to timelines with technology transfer package.
- Ensure GMP practices in formulation laboratory and manufacturing sites
- Plan and prepare stability study for samples and protocol
- Plan and prepare BE study for samples and documents or prepare bio-waiver application
- Plan and prepare documents for product registration application considering domestic and international standards; provide support for any correspondence from local and regional agencies.
- Working together with a Quality Assurance from sites to assess compliance during technology transfer; and provide necessary QA documentation for sites i.e. IR, NCR, deviation, CAPA.
- Participate in committee / OE project/ Kaizen / of the company if nominated.
- Candidate must possess at least a Bachelor's Degree, Professional Degree, Pharmacy / Pharmaceutics / Related sciences or equivalent.
- At least 7 year(s) of working experience in the pharmaceutical R&D
- Pharmaceutical development, regulatory, GMP, Analytical abilities, project management
- Full-Time position(s) available in Duopharma Innovation Sdn Bhd (Glenmarie)
- Manufacturing Unit - Duopharma (M) Sdn Bhd, Duopharma Manufacturing (M) Sdn Bhd
- Sales and Marketing Unit - Duopharma Marketing Sdn Bhd
- R & D Unit - Duopharma Innovation Sdn Bhd
- Pharmaceuticals and healthcare products and services
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