Technical Service

1 week ago


Bayan Lepas, Malaysia KCK PHARMACEUTICAL INDUSTRIES SDN BHD Full time
1. Technical Service
  • Associate Manager in Formulation Development is responsible for product development/ deployment of new formulations or up gradation for improvement of existing formulations.
New formulations are pre-commissioned or acquired from development center from India. This task is managed by Technical Service
  • Assistant Manager in Formulation Development based on Product Brief which emanates from Business Plan as developed by Marketing Director.
2. The scope transits from laboratory based pre-formulations, trial batch and product evaluation and to finish product realization. 3.

Specific responsibilities in addition includes, managing development of regulatory CMC documentation which consists of Chemistry, manufacturing and documentation for regulatory submission.

This task has to accomplish with the support of Senior Manager-TS /PL. 4.

Roles required planning, organizing raw materials, evaluating and working with QA to obtain initial approval for pilot studies for which planned scheduled for batch manufacturing for stability study, Validation Scheme, pharmaceutical development report and finalize process validation protocol and completed report.

5.

This has to be carried out in collaboration with Senior Manager-TS /PL which should provide opportunity for training to Technical Service team.

6.

Based on process validation protocol conduct process validation with a view to standardize process and also train and lead technical transfer to production.

7. Prepare and consolidate prototype BMR developed based on pilot batch manufacture. 8.

Study existing dosage forms with a view to improve and endow ruggedness to the manufacturing process to enable training and empowerment to operation technicians.

9.

Periodically Track and Review process data for retrospective data evaluation of newly deployed formulations, this will lead to compilation of Annual Product review for product improvement and to ensure consistent quality.

10. Provide participative support in QMS as an audit team member during internal audit exercise. 11. Perform any other assignment by plant management. EXPECTATION 12. Accomplishing the targeted New Product Development on time. 13. Improvement of existing product to meet market complaints. 14. Continuous Improvement of existing process for quality, safety and efficiency. 15. Able to work independently, self-motivated and have a good discipline. 16. Ensuring batch manufacturing records are in compliance to current good manufacturing practice. 17. Compile documented evidence to prove the process is robust and reproducible by conducting process validation. 18. Compile documented evidence to prove that the cleaning procedure comply within the maximum allowable carry-over by conducting cleaning validation. 19. Compliance with Safety Policy and always utilize the personal protection equipment (PPE). 20. Good discipline and sincerity are crucial for this position to ensure the quality of the products. 21. Good teamwork and be responsible.
Our Vision To provide quality products to our consumer and meet customers' needs in healthcare. Our Mission Collective talent with understanding and passion to improve our products and services each day
Master's or Equivalent
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