QA Specialist (Moscow, Russia)

PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 48 countries and more than 21,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development and optimize value in delivering life-changing therapies to improve health.

We are currently looking for Quality Assurance Specialist to join our team in Moscow, Russia / Kiev, Ukraine.

As a Quality Assurance Specialist you will provide expertise to the department covering one or more specialized quality management areas, such as GxP manufacturing, quality systems investigations and audits, lab investigations, root cause analysis, or Total Quality Management (TQM), assuring all systems, processes and their outcomes comply with applicable international and national regulations and guidelines and fulfill client and company requirements, and may include the performance of vendor and internal audits, participate in client and regulatory inspections, and/or manage the administration and reporting aspects of quality management systems.

This position offers our full benefits package as well as continued career advancement working in an office or from home within the Quality department or other departments within PPD.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team.

Essential Functions and Other Job Information:

• Participates in all activities associated with client, regulatory, vendor, quality management system and/or internal audits and investigations to include: coordination, scheduling, hosting, conduction of audits and review of audit responses.• Verifies compliance with SOPs/WPDs and contractual obligations for audit target selection and frequency of audits to ensure ongoing quality.• Liaises with several internal departments and senior management to provide full internal oversight of the GxP/GDP services provided to clients and facilitate interaction across functional, regulatory and legal teams.• Develops, updates and disseminates SOPs/WPDs as they relate to quality processes.• Performs internal and external audit related activities as needed and escalates significant issues appropriately. Continually ensures audit readiness of client files.• Contributes to quality process improvement activities to ensure the organization meets or exceeds client expectations for the implementation of quality management systems and processes.• Ensures full compliance with internal procedures pertaining to quality investigations, quality audits and quality improvement initiatives.• Performs root cause analysis. Assists in resolving critical quality issues to include CAPAs, complaints and recalls, and resolves non-critical quality issues such as deviations.• Generates reports to provide internal management with tracking, trending, informed analysis reports, process improvement data and key performance metrics.

PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 48 countries and more than 21,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development and optimize value in delivering life-changing therapies to improve health.

We are currently looking for Quality Assurance Specialist to join our team in Moscow, Russia / Kiev, Ukraine.

As a Quality Assurance Specialist you will provide expertise to the department covering one or more specialized quality management areas, such as GxP manufacturing, quality systems investigations and audits, lab investigations, root cause analysis, or Total Quality Management (TQM), assuring all systems, processes and their outcomes comply with applicable international and national regulations and guidelines and fulfill client and company requirements, and may include the performance of vendor and internal audits, participate in client and regulatory inspections, and/or manage the administration and reporting aspects of quality management systems.

This position offers our full benefits package as well as continued career advancement working in an office or from home within the Quality department or other departments within PPD.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team.

Essential Functions and Other Job Information:

• Participates in all activities associated with client, regulatory, vendor, quality management system and/or internal audits and investigations to include: coordination, scheduling, hosting, conduction of audits and review of audit responses.• Verifies compliance with SOPs/WPDs and contractual obligations for audit target selection and frequency of audits to ensure ongoing quality.• Liaises with several internal departments and senior management to provide full internal oversight of the GxP/GDP services provided to clients and facilitate interaction across functional, regulatory and legal teams.• Develops, updates and disseminates SOPs/WPDs as they relate to quality processes.• Performs internal and external audit related activities as needed and escalates significant issues appropriately. Continually ensures audit readiness of client files.• Contributes to quality process improvement activities to ensure the organization meets or exceeds client expectations for the implementation of quality management systems and processes.• Ensures full compliance with internal procedures pertaining to quality investigations, quality audits and quality improvement initiatives.• Performs root cause analysis. Assists in resolving critical quality issues to include CAPAs, complaints and recalls, and resolves non-critical quality issues such as deviations.• Generates reports to provide internal management with tracking, trending, informed analysis reports, process improvement data and key performance metrics.

Education and Experience:

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification• Relevant quality assurance experience (comparable to 2 years) including expertise in GxP regulations gained from time served in a pharmaceutical, biotechnology and/or medical device industry

Knowledge, Skills and Abilities:

• Comprehensive expertise in all aspects of pharmaceutical GxP regulations (e.g. quality systems, root cause analysis and Total Quality Management) including international regulations• Knowledge of applicable parts of 21 CFR regulations• Knowledge of EU and ICH GMP regulations• Knowledge of ISO standards where applicable• Expertise in GxP and appropriate regional clinical research regulations and guidelines• Proven proficiency with leading a range of project based or internal GxP audits and vendor audits to high standards• Superior oral and written communication skills• Expert problem solving, risk assessment and impact analysis abilities• In depth experience in root cause analysis• Excellent negotiation and conflict management skills• Ability to remain flexible, multitask, and prioritize competing demands

What we offer:

• An opportunity for a challenging and rewarding career in one of the Global Leaders in the clinical research• Thorough, top-notch training program from day one• A supportive and knowledgeable team of colleagues eager to share expertise• Nurturing and welcoming environment by offering flexibility, work-life balance and social initiatives• Global organization with high quality and standards• Competitive remuneration and social benefits package

How to apply:

If you meet the requirements, please submit your CV in English. PPD is an equal opportunities employer.

Education and Experience:

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification• Relevant quality assurance experience (comparable to 2 years) including expertise in GxP regulations gained from time served in a pharmaceutical, biotechnology and/or medical device industry

Knowledge, Skills and Abilities:

• Comprehensive expertise in all aspects of pharmaceutical GxP regulations (e.g. quality systems, root cause analysis and Total Quality Management) including international regulations• Knowledge of applicable parts of 21 CFR regulations• Knowledge of EU and ICH GMP regulations• Knowledge of ISO standards where applicable• Expertise in GxP and appropriate regional clinical research regulations and guidelines• Proven proficiency with leading a range of project based or internal GxP audits and vendor audits to high standards• Superior oral and written communication skills• Expert problem solving, risk assessment and impact analysis abilities• In depth experience in root cause analysis• Excellent negotiation and conflict management skills• Ability to remain flexible, multitask, and prioritize competing demands

What we offer:

• An opportunity for a challenging and rewarding career in one of the Global Leaders in the clinical research• Thorough, top-notch training program from day one• A supportive and knowledgeable team of colleagues eager to share expertise• Nurturing and welcoming environment by offering flexibility, work-life balance and social initiatives• Global organization with high quality and standards• Competitive remuneration and social benefits package

How to apply:

If you meet the requirements, please submit your CV in English. PPD is an equal opportunities employer.