Senior Quality Assurance Specialist / Старший спеціаліст із забезпечення якості

Responsibilities:

• 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.
• Support internal and external quality inspections and audits including reporting, response to observations and tracking of action plans.
• Establish training requirements related to Quality Systems and maintenance of a diverse and agile cross trained and effective team to ensure business continuity and compliance.
• Coordinate and investigate quality events such as deviations, non-conformances, product complaints and corresponding action plans including decisions.
• To deal with Regulatory bodies as required through using complaint reporting processes.
• Quality management of supplier qualification program including performance monitoring for key suppliers and update of Quality Technical Agreements.
• Coordinate the Quality Management Review process at the affiliate.
• Responsible for carrying out a quality self-inspection program within the affiliate.
• Execute quality plans and provide assistance to the various multi-disciplinary departments and teams with respect to planning and execution.
• Ensure metrics and KPIs are being met.
• Coordinate change control process to ensure changes do not introduce  adverse impact to operation.
• Provide guidance and support for all activities governed by Good Storage and Distribution
• Practices including monitoring of controlled temperature and cold chain shipments.
• Represent affiliate QA in regional, global and cross functional teams, projects and programs, as assigned by management.

Responsibilities –Deputy Responsible Person:

• Focus on the management of authorized activities and the accuracy and quality of records.
• Ensure that initial and continuous training programs are implemented and maintained.
• Responsible for coordinating and promptly performing any recall operations for medicinal products.
• Ensure that relevant customer complaints are dealt with effectively.
• Ensure that suppliers and customers are approved and approve subcontracted activities which may impact GDP
• Ensure that self-inspections are performed at appropriate, regular intervals following a prearranged program and necessary corrective measures are put in place.
• Decide on the final disposition of returned, rejected, recalled or falsified products.
• Approve returns to stock further to internal Quality assessment.
• Ensure that additional requirements imposed on certain products by National law are adhered to (Distributor reporting in imports, consumptions and exports).
• Ensure fulfilment of requirements as per National legislation requirements in regard to Wholesaler license.
• Oversee inspection of incoming goods and release to local market.
• Ensure that sample management is performed according to the GDP rules and all local requirements including the relevant trainings of sales representatives are followed.
• Coordinate change control process to ensure changes do not introduce adverse impact to operation.
• Assist the (RP) in releasing products for the market and in handling of temperature excursions

Qualifications:

• University Degree in Pharmacy
• 2+ years’experience in quality assurance, quality oversight or relevant experience.
• 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.
• Comprehensive knowledge of national and EU GDP legislation
• Knowledge of Quality systems and GxP compliance requirements including regulations and standards affecting device, biologics and pharmaceutical products preferred.
• Strong oral and written communication skills.
• Proficiency in English.