Syngene Biotech & Life Science Executive – BSc / MSc Apply
Syngene Biotech & Life Science Executive – BSc / MSc Apply. Biotechnology & Life Science Jobs at Syngene. Check the details on the positions available, the job description, the key responsibilities, work experience, functional experience all below:
Position: Quality Systems – Executive/ Senior Executive
Job ID: 10506
Job Description:
Quality System Management:
- Specifically, review and also revise, as required, QMS policies and procedures to guarantee the clinical development work conducted conforms to established Syngene corporate policies and industry regulations/standards.
- He/she will certainly work in collaboration with a QS lead to ensure the QMS elements are following ICH GCP/ Schedule Y as well as the required Syngene International Ltd, Corporate Policies.
- Guarantee business as well as enabling functions/departments teams are following procedures and also the QMS is operating effectively and also guarantee the QMS is understood as well as followed by all team members of Syngene Clinical Development GCP.
- He/she will be instrumental to maintain electronic QMS/ DMS/LMS and content management/ quality systems-specific tools such as SAP LMS, Track wise as well as Documentum, He/she will be instrumental to perform/ assist Implementation, coordination, training of electronic QMS/ DMS/LMS as well as various other QMS digitalization initiates.
- He/she will be responsible to perform Document control, Change control as well as management, SOP administration and Archives management activities.
- He/she will certainly be preparing metrics as well as monitoring the health status of QMS and also regulatory compliance to guarantee that Syngene Clinical Development GCP Quality systems are in state of compliance.
Audit, Corrective and Preventive Action (CAPA) Management:
- He/she will certainly be responsible to aid in preparations for external audits and regulatory inspections. participate in hosting external audits, as needed. Support regulatory inspections, along with Clinical and also Bioanalytical QA leads.
- He/she will be accountable for prep work of quality metrics as well as monitoring/tracking/follow-up the timelines for CAPA responses, CAPA implementation status for external/Internal/vendor audits and also regulatory inspections.
- He/she will support QS lead for actively track CAPAs and remain diligent to guarantee the tasks are completed on schedule.
- As required, aid team in developing solutions to problems and offer possible improvements to processes as well as systems.
Training:
Responsible for maintaining the training system for all employees by creating, updating as well as maintaining training curriculums in the LMS. Complete LMS administration tasks, such as reporting as well as performance monitoring Archives
Management:
- Responsible for performing and maintaining the internal document archival facility.
- Responsible for performing, managing and also monitoring the archival and also retrieval of clinical research documents and records with 3rd party archival facilities.
- Responsible for periodically monitor the performance of archival and also retrieval process as well as practices of 3rd party archival facilities.
Need to Have: Minimum Qualifications;
- Bachelor’s/ Master’s Degree in Life sciences/Pharmaceutical sciences/ Biotechnology or technical discipline with 2 to 5 years of experience in Quality, training or clinical research quality experience.
- Prior experience with GMP/GLP/GCP quality environment.
- Solid written, verbal, and interpersonal communication abilities in English language. High attention to details and also accuracy.
- Strong computer abilities: Good knowledge as well as experience with MS Office products (MS Excel/PowerPoint) in preparing and also collating quality systems data for preparation of metrics to be published to Senior Leadership Teams.
- Prior experience with utilizing electronic QMS/ DMS/LMS and also content management/ quality systems-specific tools such as SAP LMS, Track wise and also Documentum,
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