VADODARA · FULLTIME
Executive Supervisor - Injectable
Alembic Pharmaceuticals
Vadodara · onsite · Posted 21d ago
Sourced from
Undisclosed2–7 yrsfulltimeVadodara
About a minute. You'll make an account on the way through.
agent · working
- Read this posting0.4s
- Found the form on Naukri · 13 questions to answer1.3s
- Decided the answers for all of them2.6s
- Tailor your résumé to this role
- Waiting for you
Section · 01
About this role
- Preparation, review and approval of URS for all the manufacturing equipment, analysis and comparison of technical offer received from various vendors.
- Responsible for the trouble shooting, ongoing technical process validation, continuous process verification and process improvement.
- Implementation of cGMP and safety at all stages of manufacturing activities.
- Preparation, review of qualification/ validation documents and execution of qualification/ validation activities.
- Preparation, reviewing and approval of the new equipment (FAT & SAT) & equipment Risk Assessments, URS, DQ, FDS, IQ, OQ and PQ documents.
- Reviewing the equipment P&ID, area Layouts.
- Review and approval of Equipment validation, Process validation, Process simulation documents.
- Coordinate with MS&T for product transfer and execution of scale up and Registration batches.
- Preparation, review and approval of process flow diagrams and component specifications as per process requirement.
- Responsible for preparation, review and approval of standard operating Procedure (SOPs), operating instructions, and cleaning Instructions.
- Responsible for the preparation, review and approval of Master Manufacturing Record and Batch Manufacturing Record.
- Organize and co-ordinate training activities, preparation of documents and maintenance of training records. Oversee daily operations during the assigned shift.
- Ensure smooth transition between shifts, maintaining continuous production flow.
- Ensure documentation is up-to-date and compliant with standard operating procedures.
- Audit Compliance
- Handling of regulatory audit
Sourced from naukri
Section · 02
Skills
process validationPQIQprocess simulationOQEquipment QualificationProcess Equipment
Section · Company
About Alembic Pharmaceuticals
Alembic Pharmaceuticals
Pharma
16.6k+
employees
1907
119 years old
Vadodara/Baroda, Gujrat
India
About
Alembic Pharmaceuticals is a leading Indian pharmaceutical manufacturer, producing a variety of products and specializing in anti-infective medications with extensive manufacturing capabilities.
Industries
PharmaReal EstateEngineering & ConstructionBiotechnology
Employee ratings
3,943 reviews
3.9/ 5
Culture
3.7
Career growth
3.5
Work-life
3.8
Employees rate it well for
Work Culture494Senior Management278Salary247Work Environment201Job Security184
Find them on