JOB DESCRIPTION
1. Develops and validates methods for testing of batches for manufactured products.
2. Develops and validates methods for new or existing bespoke products on the stability program.
3. Prepares analytical method development, validation and test reports.
4. Writes/Reviews of specification. Supports on all analytical activities.
6. Participates in self-inspection and regulatory inspections.
7. Prepares quality reports and submit to immediate superior
8. Performs the daily operations of the Stability Program.
9. Performs responsibilities for the organization, maintenance, operation, and date review required for the Drug Stability Program which is utilized for the evaluation of the stability of pharmaceutical drug products.
15. Develops and maintain the stability protocols for all products according to FDA guidelines and approved submissions/commitments.
16. Assures that all stability samples have been properly placed on stability at the correct stability conditions.
17. Follows the requirements of the Stability Protocols and helps maintain all required timelines (sample maintenance and documentation of test results)
18. Maintain stability documentation and stability chambers as required.
19. Interacts with the QC and RAD as well as with the appropriate Quality Assurance, Technical Operations and Regulatory areas.
20. Interacts with members and development teams, bringing the Stability perspective to bear on planned activities including study scheduling versus other studies planned within the function.
21. Tracks effectively stability data and perform trend analysis of this data.
22. Review analytical data to recognize potential trends and alert.
23. Maintain the activities of the Stability Area in compliance with cGMPs, SOPs, good documentation practices and safety standards I accordance with corporate, regulatory and timeline expectations.
24. Maintains productive communications with co-workers and internal colleagues in Quality Control, Quality Assurance, RAD Assurance, RAD, Technical Operations and Regulatory Affairs.
JOB QUALIFICATION
College graduate or equivalent
OTHER JOB REQUIREMENTS
WORK LOCATION
CaloocanCOMPANY PREVIEW
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COMPANY OVERVIEW
We are a toll manufacturing company working with pharmaceutical traders and distributors in the food services and dietary supplements industry in the Philippines and in Asia for over 15 years, producing goods in various innovative formats.
Founded in Catanauan, Quezon Province in 2004 during the hype of the benefits of virgin coconut oil, we are the first manufacturing company that exclusively produced the patented 'Growrich Virgin Coconut Oil in Hard Gel Capsule', supplying local and export demands.
To ensure top quality and safety for our clients and end-users, we manufacture in compliance to the current Good Manufacturing Practices (GMP) standards under the supervision of the Food and Drug Administration (FDA).