Associate Scientist - Biotech R&D

Job Description

1. Review of Biotech R&D Documents as per ALCOA++ requirements, metadata review,

and data integrity checks.

2. Review of Process Development Reports, Tech transfer documents, Process

Characterization Reports. Co-ordination from DOA end to support for Tech

transfer activities. Review of Clone Development, Clone Characterization and

Packaging Documents.

• 3. QAMS review support for evaluation and approval of Quality Management
• notifications such as deviation, Change Control, CAPA and LIR.
• 4. QAMS Management: Tracking of QAMS Notifications, co-ordination with R&D
• for QAMS related activities, Periodic Review and Trending as per SOP and
• troubleshooting of QAMS system .
• 5. Co-ordination with CQA and HO-IT for implementation of Corporate SOPs at
• Biotech R&D and Management of QAMS for R&D Biotech site for Corporate

Change Controls.

1. Conducting Internal Audit for R&D for compliance checks.
2. Support in implementing new systems at R&D as part of system improvisation.
3. Support in Archival, Issuance and destruction of R&D documents.

Work Experience

6-10 Years

Education

Post Graduation in Biotechnology or BiotechnologyB.Tech in Biotechnology or Biotechnology

Competencies

CollaborationCustomer CentricityDeveloping TalentInnovation & CreativityProcess ExcellenceResult OrientationStakeholder ManagementStrategic Agility