Regulatory and QA Officer-Pharma Brands

2 weeks ago


Manila, National Capital Region, Philippines INTEGRATED MARKET SERVICES (PHILIPPINES), INC. Full time

RA Function:

Regulatory compliance of products
imported and distributed by the company thru out its life cycle.

Product Registration and Licenses
o Product communications compliance/ acceptability
o Company guidance on regulation updates
o Represent the company to regulating bodies and Industry Associations to protect company
interests in ethical ways
o Ensure product Labeling compliance

Other tasks as required 5%
o Assist securing BOC permits concerning product requirements
o Represent the company in FDA audits (routine or Adhoc)
o Secure product permits/ licenses if outside FDA

Operational tasks related to own customer segment

Support collection of tender documentationMonitor preparation and submission of registrationsTake care of escalations e.g. related to product approvalsSupport warehouse in case of product questions and/or deviations with incoming and outgoing goodsRisk Assessments of transport routesConfigure and follow up on temperature loggers and review of data, including documentation and archivingAssist warehouse in packing cool shipmentsTranslations of leaflets and manualsHandling of operational deviations, claims and CAPAsApplication of controlled substance licensesSupport to sales department in connection with tenders and specific customer requirements related to qualitySupport the organisation with technical product clarificationsOperational tasks related to own customer segmentSupport collection of tender documentationMonitor preparation and submission of registrationsTake care of escalations e.g. related to product approvalsSupport warehouse in case of product questions and/or deviations with incoming and outgoing goodsRisk Assessments of transport routesConfigure and follow up on temperature loggers and review of data, including documentation and archivingAssist warehouse in packing cool shipmentsTranslations of leaflets and manualsHandling of operational deviations, claims and CAPAsApplication of controlled substance licensesSupport to sales department in connection with tenders and specific customer requirements related to qualitySupport the organisation with technical product clarifications Corporate Quality Management System Ensure compliance to GDP, ISO 9001, ISO 13485, local laws and regulationsEnsure that SOPs are maintained and updated according to applicable requirementsDevelop Quality Management System and assure quality oversight from Corporate QualityParticipate in ISO group and conduct internal audits.Prepare for and participate in external audits performed by competent authorities and notified bodies as well as customers and suppliersHandling of system related deviations, claims, CAPAs and Change RequestsTraining of colleagues globally in relation to responsibilities Dedicated responsibilities Pharmacovigilance; agreements, training, complianceCorporate responsible for registration strategy in collaboration with the commercial departmentsQualifications:Candidate must possess at least Bachelor's/College Degree preferably in Pharmacy/Pharmacology, Engineering (Industrial), or equivalent.Licensed PharmacistDetail oriented, inventory management, warehousingAt least 2 Year(s) of working experience in the related field is required for this position.Knowledgeable in maintaining product quality and ensure compliance with global regulations and industry standards, handling and distributionKnowledge in GDSP, ISO 9001, Quality and Compliance, Internal Quality Auditing and process imporvement is an advantage

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