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À propos
The information below covers the role requirements, expected candidate experience, and accompanying qualifications.
Qualifications & Validation Engineer – Quality Assurance (QA)
Responsibilities:
Quality oversight of qualification and validation tasks in his/her area
Preparing and reviewing qualification and validation documentation, including protocols, reports, risk assessments, and traceability matrices according to pre‑defined timelines
Ensuring proper documentation of deviations, non‑conformances, and corrective actions
Ensuring proper evaluation (validation expertise) of change controls
Ensuring all qualification and validation activities comply with regulatory requirements (e.g., FDA, EMA) and company quality standards
Participating in internal and external audits and inspections, providing necessary documentation and support
Cooperating with cross‑functional teams, including engineering, manufacturing, and quality control, to ensure smooth execution of validation activities
Providing qualification and validation expertise when requested
Identifying opportunities for improving qualification and validation processes and contributing to continuous improvement initiatives
About you:
Degree in science (e.g., Chemistry, Microbiology or IT preferred) or Engineering (Chemical/Mechanical/Electrical) discipline
Minimum 5 years of experience in Validation and/or QA within the pharmaceutical/biotech industry
Natural influencer and works well as part of a multifunctional team
Highly motivated and self‑resilient
Adaptable and flexible as well as a pragmatically minded problem solver
Technical skills:
Strong understanding of process validation principles and lifecycle approach; understanding of cGMP regulations: FDA 21 CFR Parts 210/211, EU GMP Annex 15, FDA Process Validation Guidance (2011) and EMA process validation requirements, working knowledge of ICH Q8, Q9, Q10, Q11 guidelines
Familiarity with qualification of equipment, utilities, and manufacturing systems xcfaprz
Strong knowledge of data integrity principles (ALCOA)
Experience with deviation management, CAPA, and change control systems
Proficiency in preparing and reviewing qualification and validation documentation, including protocols, reports, and standard operating procedures (SOPs)
Excellent project management capabilities with ability to manage multiple priorities
Expertise in conducting risk assessments, analyzing validation data, and resolving deviations and non‑conformances
Excellent communication skills to effectively collaborate with cross‑functional teams
Strategic thinking with focus on balancing compliance requirements with business needs
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Compétences linguistiques
- English
Avis aux utilisateurs
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