Syngene Quality Systems Executive – Pharma Job Opening

Job Title: Quality Systems – Executive/ Senior Executive (10506)

Must-Have: Minimum Qualifications;

• Bachelor’s /Master’s Degree in /Pharmaceutical sciences 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.
• Strong written, verbal, and interpersonal communication skills in the English language. High attention to details and accuracy.
• Strong computer skills: Good knowledge and experience with MS Office products (MS Excel/PowerPoint) in preparing and collating quality systems data for preparation of metrics to be published to Senior Leadership Teams.
• Prior experience with using electronic QMS /DMS/LMS and content management/quality systems-specific tools such as SAP LMS, Track wise and Documentum,

Quality System Management:

• Specifically, review and revise, as needed, QMS policies and procedures to ensure the clinical development work conducted conforms to established Syngene corporate policies and industry regulations/standards.
• He/she will work in collaboration with a QS lead to ensure the QMS elements are following ICH GCP /Schedule Y and the required Syngene International Ltd, Corporate Policies.
• Ensure business and enabling functions/departments teams are following procedures and the QMS is operating effectively and ensure the QMS is understood and 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 and Documentum,
• He/she will be instrumental to perform/ assist Implementation, coordination, training of electronic QMS /DMS/LMS and other QMS digitalization initiates.
• He/she will be responsible to perform Document control, Change control and management, SOP administration and Archives management activities.
• He/she will be preparing metrics and monitoring the health status of QMS and regulatory compliance to assure that Syngene Clinical Development GCP Quality systems are in state of compliance.
• Audit, Corrective and Preventive Action (CAPA) Management:
• He/she will be responsible to assist in preparations for external audits and regulatory inspections. participate in hosting external audits, as needed. Support regulatory inspections, along with Clinical and Bioanalytical QA leads.
• He/she will be responsible for preparation of quality metrics and monitoring/tracking/follow-up the timelines for CAPA responses, CAPA implementation status for external/Internal/vendor audits and regulatory inspections.
• He/she will support QS lead for actively track CAPAs and remain diligent to ensure the tasks are completed on time.
• As needed, assist the team in developing solutions to problems and offer possible improvements to processes and systems.

Training:

• Responsible for maintaining the training system for all employees by creating, updating and maintaining training curriculums in the LMS. Complete LMS administration tasks, such as reporting and performance monitoring

Archives Management :

• Responsible for performing and maintaining the internal document archival facility.
• Responsible for performing, managing and monitoring the archival and retrieval of clinical research documents and records with third party archival facilities.
• Responsible for periodically monitor the performance of archival and retrieval process and practices of third party archival facilities.

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