QMS Supervisor
ARKRAY Industry, Inc.
- Santo Tomas, PhilippinesBarangay Santa Anastacia , Batangas, Pan - Philippine Hwy, Santo Tomas, 4234 Batangas, PhilippinesSanto TomasBatangasPhilippinesPhilippines
- Full timeFULL_TIME
Expired 7 years ago
2017-04-08T16:00:00+00:00Job Description
- Assist in processing of product registration and license to operate renewal with Philippine FDA.
- Guide his/her staff in timeliness of complaint handling.
- Spearhead the implementation and maintenance of Quality Management Systems.
- Lead QMS internal audits in the facility to verify compliance per set standards and requirements.
- Assist the Manager in the US FDA and other QMS Systems Compliance.
- Ensure company compliance to Change Control, Document and Data Control, Deviation Control, and CAPA Control systems.
- Guide staff in the implementation of 5s, Teian, and Kaizen Systems.
- Prepare necessary QA reports and submit to Immediate Superior as requested.
- Improve certification process to enhance customer satisfaction.
- Simplify QMS documentation by adapting initiatives to effectively control and manage the system.
Minimum Qualifications
- Bachelor of Science in Pharmacy.
- Having a license is an advantage.
- At least three years of equivalent experience in a manufacturing set-up preferably in an ISO 13485 certified company.
- Qualified auditor or has experience with QMS Audits.
- Preferably with experience in US FDA audits handling.
- Ability to write QMS procedures and can judge suitability of working instructions and procedures.
- Proficient in communication skills both written and oral
Perks and Benefits
Paid Holidays
Paid Vacation Leave
Paid Sick Leave
Maternity & Paternity Leave
Special Leave Benefits for Women
Medical / Health Insurance
Transportation Allowances
Performance Bonus
Required Skills
- Medical Industry Knowledge
- Quality Assurance
- Critical Thinking
- Monitoring and Evaluation
Licenses and Certifications
- Broker’s Licence by Professional Regulation Commission
Preferred Courses
- Pharmacy
Jobs Summary
- Job Level
- Associate / Supervisor
- Job Category
- Manufacturing and Production
- Educational Requirement
- Bachelor's degree graduate
- Recruiter response to application
- Once in a while
- Office Address
- Barangay Santa Anastacia , Batangas, Pan - Philippine Hwy, Santo Tomas, 4234 Batangas, Philippines
- Industry
- Medical Equipment
- Vacancy
- 1 opening
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About ARKRAY Industry, Inc.
ARKRAY Industry, Inc. a subsidiary of ARKRAY Factory, Inc. situated in Konan, Shiga, Japan was established on August 2011. We are 100% Japanese owned company which operates under the export processing zone of First Philippine Industrial Park, Sta. Anastacia, Sto. Tomas, Batangas. ARKRAY Industry, Inc. is established to engaged in, operate, conduct and maintain the business of manufacturing, importing, exporting, buying, selling or otherwise in at wholesale goods such as, but not limited, to blood glucose meters, test strips, safety lancets, clinical chemistry, and urine chemistry and other related developed new goods of similar nature, and any equipment, materials, supplies used or employed in or related to the manufacture of such finished products. ARKRAY Industry, Inc. begun its production on September 2011 with objective to produce and supply not only in Asia and Middle East but to Europe and United States as well. The facilities have huge area for future expansion to cater the demands of this challenging global market.