TaguigPrimary Job Function Working with the regional QA organization to provide support and guidance Commercial Affiliate QA:
Assure products distributed conform to current Good Manufacturing Practices (GMP)/Good Distribution Practices (GDP), Company Corporate and Divisional Quality standards, and other applicable regulatory standards in order to assure readily available supply of compliant, authentic, safe and efficacious products at market competitive cost.
Assure that quality related issues associated with products distributed by the affiliates conform to current Good Manufacturing Practices (cGMP)/Good Distribution Practices (cGDP), Quality standards, and other applicable regulatory standards.
Core Job Responsibilities
Reporting to Commercial and Distribution QA APAC, key responsibilities will include:
Provide GxP support to Affiliate in terms of management of distribution complaints, non-conformances, planned deviations, product action, change control and audit (internal and external)
Work in close collaboration with relevant stakeholders (i.e. Supply Chain, Global Security, Master Data, Global Distribution, TPM QA) in order to deliver inputs in compliance with GxP requirements
Maintain training plans for Commercial QA
Provide overall technical and documentation support to commercial affiliates
Participate in Distribution projects to provide QA compliance and manage projects and programs as assigned by BU Management
Represent the Commercial Affiliates on Cross-Region/Divisional and/or Corporate teams
Provide support in the review of quality agreements as necessary between quality system providers
Collating and updating metrics and data for monthly management review elevation to Region & also for facilitating/running the monthly/quarterly Management Review meeting.
Interfaces with several multi-functional areas, such as Commercial, Distribution, TPM QA Operations, etc. to document, review, and resolve metric performance reporting issues.
Other responsibilities, as assigned.
Supervisory/Management Responsibilities
None
Position Accountability / Scope
Position reports to and is accountable to the Commercial and Distribution QA Manager, APAC. The role is responsible to provide support to APAC commercial affiliates in the implementation of cost effective quality system solutions and maintain compliance with regulatory requirements.
Minimum Education
College or University degree required, technical (life Sciences) or business-related discipline
Minimum Experience/ Knowledge Required
5+ years in a Pharmaceutical or related industry
Manufacturing or Quality related experience
Knowledge of relevant regulations for commercial and distribution
Must be able to effectively deal with problems and internal customers.
Proficient with Microsoft Office Suite (intermediate MS Excel knowledge required), Adobe Acrobat, Visio, MS Access. System experience preferred using Trackwise, Isotrain, SAP and general IT system data entry and report generation desired
Sound decision-making skills contributing to high levels of competence, confidence and credibility are required
Ability to communicate both written and orally, to all levels of management and across different cultural backgrounds with well-developed interpersonal, communication and negotiation skills
