Qualification and Calibration Section Head
EVA Pharma
Employer Active
Posted 14 hrs ago
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Nationality
Any Nationality
Gender
Not Mentioned
Vacancy
1 Vacancy
Job Description
Roles & Responsibilities
Key Responsibilities:
Develop and implement the site Qualification Policy, holistic VMP, and qualification/calibration strategies to ensure full cGMP compliance for all facilities, systems, equipment and instruments.
Lead planning and execution of qualification and calibration activities (including FAT/SAT, validation lifecycle, protocols and related documentation), ensuring clear, audit-ready evidence of compliance.
Manage, organize and coach the Qualification and Calibration team, defining workflows, delegating tasks, and building capabilities for both routine and complex activities.
Oversee qualification and calibration documentation, support change controls, deviations, investigations, CAPAs and SOP updates, and ensure risk-based prioritization of critical systems impacting quality, efficacy and data integrity.
Represent qualification and calibration during internal and external audits and regulatory inspections, presenting a clear picture of compliance status and validation efforts.
Ensure robust EHS and safety culture within the team, maintaining compliance with all safety policies and quality systems, and ensuring adherence to cGMP processes, procedures and instructions.
Collaborate cross-functionally to meet project timelines, resolve technical issues related to qualification and calibration, and handle additional duties within the section s scope.
Desired Candidate Profile
BSc in Chemical/Electrical Engineering, Science or a related scientific field; a Master s degree is an added advantage.
Minimum 15 years of pharmaceutical industry experience, including at least 5 years in a similar qualification/calibration leadership role.
Formal training in GMP, qualification and calibration, with strong competency and awareness of ISPE, WHO, PIC/S, GAMP and relevant global and local standardsbr>
Solid knowledge of quality systems and project management, including experience in managing budgets and qualification/calibration programs. br
Proven leadership, team-building and people-management skills, including staffing, delegation, performance management and capability development. br
Strong analytical, problem-solving and communication skills, with excellent computer proficiency. justone+1
Demonstrated ability to lead and train integrated cross-functional teams, working under normal job-related stress to meet qualification project deadlines./p>
Company Industry
- Pharma
- Biotech
- Clinical Research
Department / Functional Area
- Quality
- Testing
- QA
- QC
- Inspector
Keywords
- Qualification And Calibration Section Head
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EVA Pharma
Join EVA Pharma, a leading pharmaceutical company dedicated to empowering the fight for health and well-being as a fundamental human right. Recognized and certified as the best place to work, we are committed to fostering a supportive and innovative environment for our team members. /p>