CSV Specialist for Pharmaceutical Sector
2 months ago
Key Responsibilities:
- Deliver Computerized System Validation (CSV) and Computerized System Assurance (CSA) consulting services tailored for pharmaceutical and medical device manufacturing organizations.
- Oversee the System Development Life Cycle (SDLC), including risk assessment, deviation management, and change control processes.
- Uphold Good Documentation Practices while collaborating with policy and procedural governance, assessments, and documentation.
- Create and implement Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) scripts, qualification protocols, and reports, adhering to industry standards and client documentation systems.
- Analyze and evaluate system functionalities and processes to produce validation deliverables.
- Formulate strategies using science- or risk-based methodologies that align with regulatory expectations.
- If in a senior role, act as the Lead for CSV services across various disciplines, including:
- Production and Manufacturing Systems (e.g., MES, DCS, Historian)
- Laboratory Instruments and Equipment (e.g., LIMS, Empower)
- Engineering and Automation (e.g., BMS)
- Emerging Technologies (e.g., SaaS platforms, Cloud systems)
Professional Qualifications:
- Bachelor's degree in a technical field such as Engineering, Science, or IT; graduates from related disciplines are also encouraged to apply.
- A minimum of 2 years of experience in CSV activities.
- Familiarity with engineering and process automation systems such as DCS, Historian, MES, and/or PLC is advantageous.
- Ability to convey quality and risk-related concepts to both technical and non-technical audiences.
- Strong written and verbal communication skills, along with proficiency in presentation and data analytics.
- Proven capability to work effectively in teams as well as independently.
- Excellent organizational skills with a commitment to completing tasks on time and with attention to detail.
- Foundational knowledge of ICH Q7/Q9, 21 CFR Part 11, EU Annex 11, and other regulatory requirements.
- Experience in software development and troubleshooting, including languages such as C#, JavaScript, Visual Basic, and database management (SQL) is preferred.
- Experience in supporting Manufacturing Automation and IT, as well as managing SDLC processes like change, issue, incident, and release management.
- Understanding of ISO9001, GAMP5, ISA88, ISA95, and other relevant pharmaceutical standards and best practices.
What We Offer:
- Consulting roles focused on pharmaceutical and medical device clients in strategically significant projects.
- A professional consultancy environment within a highly motivated team.
- Opportunities to enhance skills and manage projects in both technical and validation scopes.
- Chances to take on responsibilities and influence organizational development.
- Excellent career advancement and growth opportunities within a leading consulting firm.
- A structured training program complemented by a peer mentoring system to foster competence and personal development.
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