Quality Auditor - Pharmacovigilance jobs in Ahmedabad at Lambda Therapeutic Research Limited

Quality Auditor - Pharmacovigilance

Required Experience – 1 Year to 5 Years
Required Qualification – Any Science Graduate
Location - Ahmedabad

Key Responsibilities :

Oversight of overall PV-QA activities
Management of SOPs and Document Control:
Development, including review and sign off of new and existing company SOPs, oversight of control and issue of
SOPs internally and to clients including affiliates as required. Contribute to development of a robust mechanism for issue of electronic SOPs. Management/facilitation of timely SOP training for staff and clients in relation to issue/effective date. Develop and manage a documented internal system (SOP) for formal approval, issue and control of company
templates/forms to be accessible via server. To ensure that all SOPs/WIs/Guides are in accordance with relevant regulations and revised periodically to
update the changes in legislation pertinent to Pharmacovigilance. Development of multiple-choice SOP questionnaires as part of SOP issue and acknowledgement of receipt to
achieve documented competency testing.
Involvement in development of customized document management system, with electronic signature functionality
and related regulatory considerations. Management of Change Control. Review of Voids, Nullification and drug addition/deletion form
Training
Ensures that all personnel of Lambda Therapeutic Limited are appropriately trained on the use of PV SOPs and
that records of training are maintained. Ensures that each revision of any SOP is documented and additional training is provided on the updates. Oversees the design and implementation of training programs for pharmacovigilance. Co-ordination of training for team as per respective training SOPs

Lambda offers full spectrum clinical trial solutions empowered by more than 14 years of service to the biopharmaceutical and generic industry. At Lambda, our gamut of services under the clinical research domain are executed with comprehensive efforts, to deliver positive results. Led by a management team of highly qualified & experienced industry leaders, we apply innovative technologies, therapeutic expertise and a commitment to quality in order to help clients develop products safely, effectively and quickly.

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