Executive

2 days ago

Vadodara, India Sun Pharmaceutical Industries Ltd Full time

Key Responsibilities:
Responsible for analytical method qualification for all pipeline products.
Characterization of innovator product batches sourced from different geographical region and preparation of quality target profile.
Analytical similarity assessment of in-house products.
Preparation and review of method development reports (MDR) and analytical test procedures (ATP).
Responsible for operating and maintaining analytical laboratory in compliance with GLP regulations.
To manage chemicals,consumables & critical reagents inventory. Performs calibration of instruments and equipment. Troubleshoots instrument performance and equipment issues.

Responsible for managing the regulatory queries.
Educational Qualification:
M.SC./ in Biochemistry / Life Sciences / Biotechnology.
Technical/functional Skills:
Sound knowledge of analytical method development, qualification and structural and functional characterization of therapeutic proteins.
Experience of biosimilarity assessment of biologics for regulated market is desirable.
Experience of analytical development for monoclonal antibodies and peptide is highly desirable.
**Experience**:
2 to 6 years of relevant industrial experience
Behavioral Skills:
Highest emphasis on Ethics and Data Integrity
Commitment to maintaining Safe work practices and Safety compliant Behaviour at workplace
Commitment to Quality, Compliance, Efficiency, Cost, On-Time Delivery
Effective Communications skills (verbal and written) is desirable.
Proactive nature with excellent interpersonal skills to build and maintain professional working relations
Ability to handle cross-functional requirements.
Work collaboratively with other team members in an effective and cordial manner

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