Ensures that the quality risks are correctly assessed and identified. Leads the Quality Control Team and product development procedures to meet customer expectations.
A. Primary function
- Responsible for the overall Quality Control Program of the Manufacturing which includes scope, frequency, methods of sampling, and testing.
- Knowledgeable in method validation and Multi-point Dissolution.
- Prepare on-time Quality Control report to summarize test results and coordinate with the concerned department for necessary actions.
- Analyzes raw materials, intermediates, bulk products, and finished products as per documented analytical procedures.
- Responsible for providing testing disposition of raw and packaging materials, in-process samples, and finished products according to defined specifications within the agreed lead time.
- Maintain the QC Laboratory to ensure continuous support to the operations and compliance to Good Laboratory Practices (GLP) and review its capacity based on current needs.
- Participate in appropriate technical seminars, conferences, and workshops to develop competency and familiarity with the latest developments in the field of chemical testing.
- Provide statistical input into the development of plans and justification of results using statistical and quality risk management tools (design of experiment, failure mode and effect analysis, hazard analysis, fault tree analysis).
- Assist with test method modifications, development, and validation of new analytical methods.
- Responsible for interpreting complex analytical results, troubleshooting and developing complicated methods and techniques, and completing development, application, and validation of work (protocol drafting, data collection, and preparation of report).
- Recognize results that deviate from established standards, specifications, and trends and independently recommend appropriate actions.
- Perform testing necessary to investigate out-of-specification (OOS) test results.
- Complete OOS reports including corrective and preventive actions independently.
- Support and monitor testing of new formulations and stability products.
- Review and approve testing documentation of other analysts.
- Prepare analytical reports and certificate of Analysis.
- Use strong analytical, problem-solving, and independent decision-making skills.
- Conduct in-house calibration of instruments.
- Perform regular portability tests of process and drinking water to ensure compliance with standards.
- Train and develop other Technical Services Department associates.
- Prepare and revise Standard Operating Procedures by biannual review.
- Update current methods as necessary using the change control system.
- Organize and schedule of work workload for team members.
- Enforce safety procedures and report safety incidents
- Plan, oversee, and implement the departmental objectives in meeting the company’s strategic plans.
- Conduct raw material audits.
- Coordinates inter-departmental quality activities
B. Perform other related duties that may be assigned from time to time.
Job Qualifications
- BS degree in Chemistry, and must be a Licensed Chemist.
- At least three (3) to five (5) years experience in QC in a pharmaceutical firm, with a minimum of two (2) to three (3) years in a Supervisory position under Quality Control Management.
- Strong knowledge of Standard Operating Procedures and compliance with Good Laboratory Practices, Good Documentation Practices, and Current Good Manufacturing Practices.
- Strong working knowledge of technical and quality concepts of the manufacturing and testing of pharmaceutical products.
- Experience in participating in deviation investigations, determining root cause, and developing corrective action plans.
- Team player with strong interpersonal, organizational, communication and skills.
- Good moral character.
Job Type: Full-time
Benefits:
- Company Christmas gift
- Company events
- Employee discount
- Free parking
- Opportunities for promotion
Ability to commute/relocate:
- Carmona, Cavite: Reliably commute or planning to relocate before starting work (Required)
Work Location: On the road