Compliance Manager (GAMP 5) in Sigma Software

Compliance Manager (GAMP 5) Київ, Львів, Дніпро, Одеса, Вінниця, Івано-Франківськ, Луцьк, Тернопіль, Черкаси, Чернівці, Варшава (Польща), віддалено Weare looking for anexperienced Compliance Manager tohelpus build QMS byGAMP 5and GMP standards regulations. You will manage, design, and implement compliance policies and procedures, internal audits, and risk assessments inalignment with these standards. Responsibilities Interpreting and Implementing Regulations: Stay updated with GAMP 5and GMP regulations toensure compliance Translate complex GAMP 5and GMP requirements into actionable policies and procedures Policy Development: Develop and maintain compliance policies, procedures, and guidelines specific toGAMP 5and GMP Monitoring and Auditing: Monitor ongoing compliance with GAMP 5and GMP Conduct internal audits toidentify compliance gaps and areas for improvement Training and Education: Train employees tounderstand and adhere toGAMP 5and GMP compliance requirements Educate staff onthe implications and consequences ofnon-compliance Risk Assessment and Management: Identify potential compliance risks related toGAMP 5and GMP Develop and implement strategies tomitigate identified risks Staying Current with Regulatory Changes: Keep abreast ofchanges inGAMP 5, GMP, and related regulations orbest practices Requirements Regulatory Knowledge: In-depth understanding ofGAMP 5or IEC 62304 guidelines and regulations Quality Management Systems (QMS): Experience inestablishing and maintaining QMS compliant with GAMP 5, GMP, IEC 62304, 21CFR 820 Risk Management: Proficiency inconducting risk assessments and implementing risk management processes Computer System Validation (CSV): Familiarity with the principles and practices ofcomputer system validation related toGAMP 5 Compliance with International Standards: Knowledge ofinternational regulatory requirements relevant toGAMP 5, GMP, IEC 62304, 21CFR 820 Auditing: Strong background inconducting internal and external audits under GAMP 5, GMP, IEC 62304, and 21CFR 820 standards Communication Skills: Ability tocommunicate complex regulatory requirements clearly and effectively Upper-Intermediate level ofEnglish and higher Atleast 2years ofexperience inasimilar position ___________________________________________________________________________________________________ Мишукаємо досвідченого Compliance Manager , готового допомогти нам побудувати систему управління якістю (QMS) відповідно довимог стандартів GAMP 5та GMP. Тиуправлятимеш, розроблятимеш тавпроваджуватимеш політику тапроцедури відповідності, внутрішні аудити таоцінку ризиків відповідно доцих стандартів. Задачі Розуміння тавпровадження правил: Бути вкурсі вимог GAMP 5та GMP, щоб забезпечити їхдотримання Перетворювати складні вимоги GAMP 5та GMP удієві політики тапроцедури Розробка політики: Розробляти тапідтримувати політику, процедури тарекомендації щодо дотримання вимог GAMP 5та GMP Моніторинг тааудит: Контролювати постійну відповідність вимогам GAMP 5та GMP Проводити внутрішні аудити для виявлення прогалин удотриманні вимог таобластей для вдосконалення Навчання таосвіта: Навчати працівників розуміти тадотримуватисof GAMP 5 and GMP requirements Inform personnel about the results and consequences of non-conformance Risk assessment and management: Identify potential compliance risks related to GAMP 5 and GMP Develop and implement strategies to reduce identified risks Awareness of regulatory changes: Be aware of changes in GAMP 5, GMP and related regulatory documents or best practices Requirements Regulatory knowledge: Deep understanding of GAMP 5 or IEC 62304 guidelines and rules Quality Management Systems (QMS): Experience in establishing and maintaining a QMS in accordance with GAMP 5, GMP, IEC 62304, 21CFR 820 Risk Management: Ability to conduct risk assessments and implement risk management processes Computer Systems Validation (CSV): Knowledge of computer systems validation principles and practices related to GAMP 5 Compliance with international standards: Knowledge of international regulatory requirements applicable to GAMP 5, GMP, IEC 62304, 21CFR 820 Auditing: Significant experience conducting internal and external audits in accordance with GAMP 5, GMP, IEC 62304 and 21CFR 820 standards. Communication skills: The ability to clearly and effectively explain complex regulatory requirements. The level of English is Upper-Intermediate. Minimum of 2 years of work experience in a similar position.