SYNGENE Career Opportunities: Quality Systems -
Executive/ Senior Executive Master's in Life sciences / Pharmaceutical sciences
/Biotechnology or related technical discipline
Job Description:
Key Responsibilities:
Responsible for handling and supporting the
maintenance of following electronic systems and other paper based systems.
E-Quality Management Systems (Track Wise).
E-Document Management Systems (Open text
Documentum).
E-Learning management systems (SAP Success
factors).
Document and data archival systems and its
associated applications as per the procedures and support the Quality System
lead for improvements in consultation with GCP Quality
Head as required by the
organization and its corporate quality policies.
Support the Quality Systems(QS) lead and ensure
the site is compliant with Quality
Management Systems, the quality regulations
and standards required for clinical
development operations and ultimately is
audit ready.
Safety & Compliance:
Possess the knowledge and exposure to
environment, health, and safety (EHS) practices.
Follow environment, health, and safety (EHS)
requirements at all times in the workplace ensuring individual and lab/plant
safety.
Attend training on environment, health, and
safety (EHS) measures imparted company.
Educational
Qualification: Master's in Life sciences / Pharmaceutical
sciences /Biotechnology or related technical discipline.
Technical/functional Skills:
- Good knowledge in Quality Management System.
- He/she will work in collaboration with a
QS lead to ensure the QMS elements are following ICH GCP /Schedule Y and
the required quality policies of the organization.
- Maintain electronic QMS /DMS/LMS and content
management / quality systems-specific tools such as SAP LMS, Track wise
and Documentum.
- Collate data for quality /operational metrics
preparation using MS Excel.
Experience: 2 – 6 years.
Behavioral Skills:
Strong commitment towards work, and a high
level of dedication, enthusiasm, motivation, and persuasive ability in a team.
Good speaking-listening-writing skills,
attention to details, proactive self-starter
Ability to work successfully in a dynamic,
ambiguous environment.
Ability to meet tight deadlines and prioritize
workloads.
Ability to develop new ideas and creative solutions.
Should able to work in team and flexible for
working in shifts.
Should be a focused employee.
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