Affiliate Qa Specialist - Global Healthcare Company
- ogłoszenie wygasło 2 miesiące temu
- Umowa o pracę
- Specjalista (Mid / Regular)
The Affiliate Quality Assurance Specialist is responsible for providing quality assurance support for quality system requirements associated with: pharmaceutical products, medical devices, combination products and biologics. Specific areas of support may include Storage and Distribution, Product Complaints, potential quality events/product shortage execution, Supplier Controls, Product Quality Review, Risk Management, internal audits.
Our client is one of the leading innovative pharmaceutical companies with a global reach, one of the leaders of the modern GrowthPharma model. We are looking for Affiliate Quality Assurance Specialist based in Warsaw.
The company operates in over 100 countries around the world, based on cooperation with doctors, healthcare representatives and patients, providing modern and valuable treatment options.
- Assist with the integration and support of quality regulations: drug, biologics, device and/or combination products.
- Assist in the design of effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality systems.
- Evaluate, analyze and trend quality indicators, data and performance metrics; communication and elevation of affiliate compliance status and risk while maintaining a continuous improvement objective.
- Partner, coordinate and support activities related to quality events (quality defects, security events, recalls etc) in the affiliate.
- Assist project teams in planning, preparation, review and approval of quality documentation.
- Perform assessments to determine compliance to processes, procedures and regulations to identify potential gaps and mitigate and implement improvements.
- Coordinate and investigate quality events such as deviations, non-conformances, product complaints and corresponding action plans including decisions.
- To initiate investigation with manufacturers and to ensure suitable investigations are carried out on samples.
- Quality management of supplier qualification program including performance monitoring for key suppliers and update of Quality Technical Agreements.
- Coordinate change control process to ensure changes do not introduce negative impacts to operation
- Represent affiliate QA in regional, global and cross functional teams, projects and programs, as assigned by management.
- Bachelor's Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area preferred.
- Minimum three years of experience in quality assurance, quality oversight or relevant experience - must have
- Technical knowledge in as many of the following areas as possible: Quality, Regulatory, Process Sciences, Manufacturing Operations.
- Knowledge and familiarity with product, process, and both internal and external customer requirements.
- Knowledge of QA systems and GxP compliance requirements including regulations and standards affecting device, biologics and pharmaceutical products preferred.
- Experience working in both team setting and independently. Works well with manager guidance to complete tactical objectives while able to manage own time effectively.
- Proficiency in English.
- Excellent interpersonal skills.
- Strong computer skills and knowledge of enterprise systems such as SolTraqs, Atttache and Attache Pro - nice to have.
- Attractive compensation package
- Possibility to develop professional career in one of the biggest pharmaceutical company
- Being part of an international team