от компании (организации): PPD в городе (населённом пункте): Москва, Россия
в отрасли экономики "Медицина, фармацевтика" → "Лекарственные препараты"
с заработной платой: по договоренности
Вакансия № 14813444 добавлена в базу данных сайта Работа в Москве и Московской области (МО, Подмосковье): Воскресенье, 13 октября 2024 года.
Дата обновления вакансии № 14813444 на сайте Работа в Москве и Московской области (МО, Подмосковье): Понедельник, 11 ноября 2024 года.
Обращаем Ваше внимание, что на момент обращения к работодателю вакансия № 14813444 может быть уже занята. Администрация сайта Работа в Москве и Московской области (МО, Подмосковье) приносит извинения за доставленные неудобства.
Требования к опыту работы:
1–3 года
Тип занятости:
полная занятость
График работы:
полный день
Дополнительные сведения о вакансии: Quality Assurance Specialist (Moscow, Russia)
We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.
We are currently looking for Quality Assurance Specialist to join our team in Moscow, Russia
If you are interested in what a QA Specialist does, here are the main details about the role:
Responsibilities
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.
• 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.
If this sounds like you, make sure to check our requirements before you apply:
Education and Experience:
• Bachelor's degree;
• At least 2+ years relevant quality experience is mandatory, 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.
What we offer
At PPD we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential.
As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel.
- We have a strong will to win - We earn our customer’s trust - We are game changers - We do the right thing -We are one PPD -
If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.
Diversity Statement
PPD is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group.
Откликнуться на эту вакансию: Quality Assurance Specialist (Moscow, Russia)
Предыдущая вакансия:
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