Quality Assurance Chemist

الوصف الوظيفي
successful candidate must be able to perform each of the following satisfactorily:

Review and/or Approval of Intercept clinical SOPs and support continuous process improvements
Perform Quality reviews of clinical trial protocols and associated documentation (including informed Consent Documents, etc) as appropriate, to ensure compliance with regulations and Intercepts Standards prior to study start-up or trial initiation.
Perform routine quality review and checks throughout the lifecycle of a trial/program to ensure compliance with internal procedures as well as regulatory guidelines.
Drive CRO quality agreements aimed at ensuring quality standards are established, effectively monitored and issues are resolved promptly and effectively.
Develop a Trial Master File Review plan, conduct reviews to ensure accuracy and completeness of the study level documentation.
Report significant clinical quality deficiencies and/or risks to QA management.
Represent the Quality function at the study teams and manage direct relationship with CROs and indirectly with all clinical sites.
Participate in solving compliance issues within Quality Assurance, Clinical Operations, Regulatory Affairs, and Medical Affairs.
Support Internal Quality Audits against company Annual Audit Plan, CAPA Development, Effectiveness Checks and Oversight, Quality Management Reviews. Internal Audit Plan includes clinical investigator sites, vendors, internal processes and GCP systems.
Support auditing activities to ensure that studies are conducted in accordance with sponsor protocols, , industry guidelines, and agency regulations.
Support efforts to prepare company and clinical sites for government regulatory agency visits to include local and potentially foreign government agencies; participate as Subject Matter Expert during regulatory inspections
Support training of Intercept staff on Intercept procedures, and documentation systems to assure compliance with company policies and regulatory standards as it relates to Clinical Quality.
Perform other related duties as assigned.
Understand the legal and compliance environment and drive collaboration with the Legal and Compliance team
Drive the spirit of “ONE Team” across all functions by supporting a team approach to focus on our patients and customers as our top priorities
Make Intercept a truly desired place to work

Required Experience:

QUALIFICATIONS:

Bachelor’s degree in science or equivalent.
Minimum of 5 years of experience in a regulated environment related to pharmaceutical
Minimum of 5 years of experience specific to Quality Assurance
REQUIRED KNOWLEDGE AND ABILITIES:

A strong understanding and knowledge of saudi FDA. EU . US regulations
CAPA Development and Management experience.
Inspection experience in hosting regulatory authority inspections.
Strong verbal and written communication skills are essential.
Excellent organization and multi-tasking skills.
Exceptional interpersonal skills and problem-solving capabilities.
Proven negotiation skills.
Ability to work effectively across a matrix organization.
Ability to work independently and prioritize with minimal daily instruction.
Ability to think strategically in order to improve current processes.
Learning agility and ‘scalability’ to take on increasing responsibility as Intercept grows
Consistent demonstration and embodiment of company core values: Collaboration, Excellence, Innovation, Integrity, Passion, Patient/Stakeholder Centricity
Understanding the legal and compliance environment

المهارات
Bachelor degree in a relevant scientific discipline (Biology, Microbiology, Chemistry, etc.); advanced degree preferred
Minimum of 5+ years’ experience leading in microbiological, chemical or biochemical analytics in a pharmaceutical/medicinal GMP environment preferred
Strong management, interpersonal, communication, negotiation and problem solving skills.
Knowledge of test methods, method validation, Good Laboratory Practices (GLP)
Experience with Quality systems (LIMS, CAPAs, CCs,)
Demonstrated experience and good working knowledge of method development, method validation, troubleshooting and analytical method transfer.
Demonstrated knowledge of global regulatory frame-works.
Demonstrated knowledge & awareness of current industry issues & evolving trends in the regulated environment; both domestically & internationally.

تفاصيل الوظيفة
منطقة الوظيفة جدة, المملكة العربية السعودية
قطاع الشركة الصيدلة
طبيعة عمل الشركة صاحب عمل (القطاع الخاص)
الدور الوظيفي مراقبة الجودة
نوع التوظيف دوام كامل
الراتب الشهري غير محدد
عدد الوظائف الشاغرة 1
المرشح المفضل
المستوى المهني إدارة
عدد سنوات الخبرة الحد الأدنى: 3 الحد الأقصى: 8
منطقة الإقامة الأردن; الإمارات العربية المتحدة; البحرين; الجزائر; السودان; الصومال; العراق; الكويت; المغرب; المملكة العربية السعودية; اليمن; تونس; جزر القمر; جيبوتى; سوريا; عمان; فلسطين; قطر; لبنان; ليبيا; مصر; موريتانيا
الجنس ذكر
الشهادة بكالوريوس/ دبلوم عالي

https://www.bayt.com/ar/saudi-arabia/jobs/quality-assurance-chemist-4169093/