Parexel Hiring Quality Management Opportunities Biological science, Pharmacy or other health related disciplines Apply Now
Hyderabad, Telangana, India
Manages efforts to define,
adopt and oversee compliance to processes and standards as the fundamental
baseline for clinical trial services, technology development, validation and
delivery. Supports efforts, in collaboration with the business to monitor,
identify and implement continuous process improvement across all technology
business units.
Manages project delivery,
validation efforts, and provides expertise to ensure clinical trials and/or
technology projects adhere to established standards and quality expectations.
Supports activities to develop and perform assessments on clinical trials and
technology projects to identify and mitigate risks and prevent quality
concerns.
Skills:
• Expert in computer technology
quality and compliance (including computerized system validation) and the
pharmaceutical industry across multiple disciplines within Clinical Drug
Development (Phase I/II/III/IV) and/or Manufacturing.
• Advanced knowledge of
continuous improvement methodologies.
• Exhibits competency across
core project management activities.
• Excellent interpersonal,
verbal and written communication skills, business understanding, negotiation
skills and strong organizational skills.
• Ability to work in a
customer-focused, fast-paced and rapidly changing environment with the ability
to prioritize workload and manage multiple and varied tasks with enthusiasm and
supervision.
• Highly motivated, seeks
opportunities for development, client-focused, having the ability to work with
guidance on own initiative.
• Exhibits a sense of urgency
when addressing problems and ensures completion of commitment.
• Culturally aware and ability
to think and work globally.
• Intermediate desktop software
skills (MS Office, Excel, Adobe PDF etc.)
Knowledge and Experience:
• Expert in functionally
managing teams to meet project goals.
• Clinical trials and /or
research work experience required, with emphasis on GCP and technology
compliance.
• Expert in technology as it
relates to clinical trial activities, including System Life Cycle process and
applicable GCP regulations pertaining to Computer Systems.
• Expert of project management, Lean Six-Sigma, auditing and/or risk management methodologies.
Education:
• Educated to degree level
(technology, biological science, pharmacy or other health related discipline
preferred) or equivalent qualification, or 2+ years clinical research
experience.
• Postgraduate degree in a
science, technology or industry-related discipline preferred.
• Industry recognized
qualification i.e. project management, Lean Six-Sigma, auditing and/or risk
management.
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