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Senior Associate scientist

5.00 to 7.00 Years   Delhi   01 Aug, 2021
Sygene
Job LocationDelhi
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaBio Tech / R&D / Scientist
EmploymentTypeFull-time

Job Description

  • Development data and document management system (D3S) representative for Biopharmaceutical development (BPD) department. Responsible for improving and monitoring the quality compliance activities by acting as a bridge between BPD and Development Quality Assurance (DQA) department.
  • Actively participate in Good Research Practices (GRP), Good documentation practices (GDP), Documentation and Quality initiatives for BPD and entire organization.
  • Safety, Quality, Integrity & Compliance: Establish operational standards, implement, monitor, audit and train the BPD functions.
  • Streamline lab operations through process optimization to improve lab productivity.
  • Responsible/facilitate all client specific audits (Safety, Quality, DI, compliance etc) and ISO audits with other necessary departments and provide CAPA.
Primary Responsibilities:
  • Responsible for improving and monitoring quality of documents at Biopharmaceutical development (BPD) department.
  • Performing gap assessments related to system or functions identified for improvement.
  • Review and approval of protocols and reports.
  • Review of raw data related to the protocols and reports.
  • Issuance of protocol and report numbers.
  • Issuance of logbooks and lab notebooks and its archival.
  • Preparation and review of D3S procedures and other SOPs as per requirement.
  • Participating in investigations related to noncompliance and proposing effective corrective and preventive actions.
  • eQMS and EDMS coordinator for the department
  • Preparation of training matrix and maintenance of training binders.
  • Responsible for following the DQA and department SOPs.
  • Conducting compliance related trainings at BPD.
  • Responsible for following the safety standards at Syngene International Ltd.
  • Performing any other activities assigned by the department head.
Secondary Responsibilities:
  • Participation in Syngene wide compliance initiatives.
  • Responsible for following the safety standards at Syngene International Ltd.
  • Actively participate in Kavach initiative
,

Keyskills :
marketingdocument management systemauditingresearchquality assuranceiso auditbenefits administrationquality controlmanagement system

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