Senior QA Specialist | Microbiology and Process  

We are looking for a Senior QA Specialist for Microbiology and Process who shares the same vision and commitment in driving the agenda for quality. You will be responsible for supervising the operation of the microbiology laboratory for the examination of bacteria. Person hired will coordinate the activities of technical staff and provide technical expertise in the examination of specimens using microbiological procedures as function of quality assurance. Other function includes checking and supervision of compliance to manufacturing parameters.

Your responsibilities will include :

• Creates the Microbiological Plan and updates the document as required.

• Performs Micro Testing and Sampling for Liquid Line and Make-up lines/Balm and Soap line.

• Performs Environmental Air Sampling for production controlled areas.

• Performs Water Testing on RO.

• Creates and updates Cleaning and Sanitization Protocol (equipment, rooms, utensils etc.) and control of

alcohol usage.

• Supports Validation Activity in the Process and Filling areas.

• Creates NCR and recommends CAPA for system improvement.

• Performs Calibration/Equipment Verification and Monitoring of the Calibration Plan and Schedule.

• Works together with QMS on documentation control and revision in compliance with regulatory standards.

• Conducts Supplier Audit that requires a Micro expertise, together with other department representatives.

• Attends meeting with supplier and cross-functional team that concerns any quality issue on

products, process, equipment and materials.• Performs Analytical Method Validation for Micro, including the process area (compounding and filling).

• Creates the COA of Finished Goods upon review and approval of the Department Head.

• Initiates the cross-functional investigation for any Quality issue that may arise.

• Performs Analytical Testing inside the process area (in-process bulk).

• Maintains the highest GMP standard in the Micro Lab and Process areas.

• Supports the external audit for GKI.

• Complies with GDP in all documentations for data integrity.

• May be assigned to perform other tasks designated by the QA Head.

•Candidate must possess at least a Bachelor's degree in the field of Microbiology or Biology.

•At least 5 years of work experience in microbiology is required for this position.

•With high level leadership capabilities. Must execute tasks with minimal supervision.

•In depth knowledge on Quality System or QMS. Can create Protocols and SOP and conduct training of effective documents.

•With calibration background, GDP, GSP, GWP and GMP Certification or trainings.

•Wide experience and exposure in handling internal and external AUDITS.

•Expert in conducting Analytical tool analysis (FMEA, Cause & Effect, Why-Why Analysis, Series of Events investigation etc.)

•With validation background including equipment and process method validation.

•Very pro-active and with initiative in leading team quality issue investigation.

•Detail-oriented and with good decision-making capabilities.

•Works with Integrity especially with documentation.

•Applicants must be within the vicinity of our manufacturing plant in Carmelray 1, Canlubang, Laguna

•Guaranteed No Sunday work.