Associate Scientist

2 weeks ago

Pune RD MH IN lupin ltd Full time ₹ 4,00,000 - ₹ 8,00,000 per year

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.

6. Conducting Internal Audit for R&D for compliance checks.

7. Support in implementing new systems at R&D as part of system improvisation.

8. 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 Experience LevelMid Level

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