Purpose of the Position
The role will be accountable for management of the Quality Control, Quality Assurance and Regulatory Affairs requirement of the site.
Specific Duties & Responsibilities 1. Quality Control Management Licensed Chemist of Sta. Rosa Quality Control Laboratory, supervising the analysis and certification of the products within the scope of the ISO 17025 certification of Sta. Rosa Quality Control Laboratory.Support the quality control of other industrial and special gas products.Overall management of the Sta. Rosa Quality Control Laboratory. 2. Quality Assurance / Quality Management System Ensure the quality assurance policies and procedures are carried out in the actual product in the actual product realization and service provision to guarantee product quality.Assist in establishing and implementing in all production sites and sales centers the quality assurance policies, procedures and programs which are linked to the organization's overall objectives in fulfilling the commitment to total customer satisfaction.Ensure that product-related customer complaints are monitored, investigated, and closed within the agreed timelines, and to continually improve performance and reduce customer complaints thru the formulation of effective corrective and preventive actions.Provide technical support and training to QA Specialist/Pharmacist/PCO on laboratory procedures, product testing techniques, and quality control methodologies.Ensure the sustainable implementation of the Quality Management Systems- ISO 9001, ISO 17025 and GMP for medical products.
3. Quality and Regulatory Affairs Ensure the quality assurance policies and procedures are carried out in the actual product in the actual product realization and service provision to guarantee product quality.Acts as deputy LVO (Pharmacovigilance Officer) Required Qualification / Experience University degree in Chemistry and or PharmacyLicensed Chemist or PharmacistAt least 3 years' experience in a manufacturing environment handling Quality Control/Quality Assurance and Quality Management Systems functions.Knowledgeable in analytical test methods and laboratory techniquesProficient in MS applications (Word, Excel, PowerPoint)Industry experience is an advantage.
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