Engineer I - Lab Operator

Vantive

5 - 10 years

7 - 12 Lacs

Bengaluru

Posted:5 hours ago| Platform:

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Skills Required

Material management Lab Operator Management systems Analytical Formulation Pharma data integrity Quality compliance Recruitment Quality management

Work Mode

Work from Office

Job Type

Full Time

Job Description

Summary

Professional experience in areas like Laboratory Management, Equipment Qualifications, Material management. This position may own & perform relevant System activities for a family of Drug Products and Sciences at R&D facility.

Essential Duties and Responsibilities:

As Lab Operator, responsible for equipment qualification (URS, DQ, IQ, OQ, PQ) for Formulation Lab equipment.
Responsible for Periodic as well as daily, on-demand calibration and maintenance of formulation Lab equipment.
Responsible for Maintaining all the PPE s protective gear, glassware and consumables for formulation activities and routine operations.
Responsible for maintaining state of quality compliance in the lab as per global procedures including but not limited to lab procedures, documents, forms, lab data etc.
Responsible for setting up the batch startup requirements before execution of scale-up batches in formulation Lab.
Responsible for Material Planning & Handling before batch execution in Formulation Lab.
Ensure good internal and cross-functional communication and regular status update of activities.
Establish, maintain, and update Technical & Design documentation according to Good Documentation Practices.
Ensure Quality & Compliance with Vantive policy/Ethics/Data Integrity and Environmental Health and Safety policies.

Qualification:

Diploma in Engineering discipline with minimum 5 years of experience, or Bachelor of Engineering discipline with minimum 3 years of experience or masters in science or Pharmaceutical discipline with minimum experience of 5 years as lab operator in pharmaceutical product development and life cycle management, preferably sterile injectable/parenteral formulations are preferred.
Adequate knowledge of Equipment Qualifications and Laboratory management required for effective collaboration with cross-functions and execution of batches on time.
Adequate knowledge of Lab Equipment s, Process, and Quality Management Systems.
Adequate knowledge of international/regional/national regulations and standards.
Demonstrates flexibility and the ability to shift gears between projects comfortably.
Excellent oral and written communication skills.
Good analytical and problem-solving skill.
Good organizational skills.
Ability to effectively organize and prioritize tasks.

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