AHMEDABAD · FULLTIME

Sr Executive, QA Validation

Amneal Pharmaceuticals

Ahmedabad · onsite · Posted 40d ago

Sourced from Naukri

Undisclosed7–9 yrsfulltimeAhmedabad

About a minute. You'll make an account on the way through.

agent · working

Read this posting0.2s
Found the form on Naukri · 11 questions to answer1.1s
Decided the answers for all of them2.1s
Tailor your résumé to this role
Waiting for you

Section · 01

About this role

Key Responsibilities

To prepare and review of URS, DQ, QRM, FAT, SAT, and vendor/ supplier s documents related to qualification.
To execute Qualification / Re-Qualification and Validation activities of Equipment / System / Facility and Plant utilities (HVAC system, Autoclave, Isolator, Filling machine, Washing machine, Depyrogenation tunnel, UAFs, Packaging equipment, Water system, Pure steam generation and distribution system, Nitrogen/compressed air distribution system etc.).
To perform qualification activities like air flow visualization study, Temperature mapping of Rooms/Chambers, Packaging validation, Transport validation etc.
To co-ordinate with manufacturing, Engineering, Material Management, QC personnel and other users for respective Qualification / Validation / Re-qualification activities for timely completion of activities.
To prepare and review Validation/ Qualification protocols and reports (IOQ, PQ, RQ, CQ, other miscellaneous qualification documents etc).
To prepare and review process validation, cleaning validation, media fill and hold time study protocols and reports.
To prepare and review of SOPs of Validation and Quality Assurance Department.
To prepare and update Annual Validation Planner.
To prepare and execute project validation master plan for commissioning and qualification of new/modified facility.
To assess Change Control, Deviation, CAPA etc. and participate in investigation triggered through deviation, OOS, OOT or other failures.
To involved in QMS related activities i.e initiation and review of QMS elements.
To prepare, review and execute risk assessment activity related to equipment/ process/ facility/ system.
To conduct sampling activities as per the protocols (Hold time, Process validation and cleaning validation etc.).
Establish, monitor and maintain Validation function for audit readiness.
To prepare VMP and SMF.
To implement contamination control strategy at site.
Complete Validation Lifecycle: URS, DQ, FAT, SAT, Commissioning, IQ, OQ, PQ
End-to-end validation lifecycle (URS, DQ, FAT, SAT, Commissioning, IQ, OQ, PQ)
Qualification of equipment, utilities, and facilities in sterile injectable manufacturing environments
Process validation and cleaning validation including protocol and report preparation
Thermal validation systems and temperature mapping studies
Media fill validation principles and execution
Basic risk assessment techniques (FMEA approach)
Validation documentation management and report compilation
Use of validation management software and electronic documentation systems
Coordination and management of end-to-end qualification/validation activities

M.Sc./ B.Pharm/ M.Pharm with minimum 7-9 years of relevant experience
Hands-on experience in Qualification/Validation function within an injectable pharmaceutical manufacturing environment

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

Sourced from naukri

Section · 02

Skills

QAprocess validationcleaning validationCompilationqrmCAPAChange ControlplannerMappingAutoclaveFilling MachinePharmaceutical ManufacturingFMEAManufacturingHVACQCDistribution SystemPharmaceuticalmaterial management

Section · Company

About Amneal Pharmaceuticals

Amneal Pharmaceuticals

Pharma

5.5k+

employees

2002

24 years old

Bridgewater, New Jersey

United States (USA)

About

Amneal Pharmaceuticals operates in the pharmaceutical sector, focusing on developing accessible and affordable medicines to address critical healthcare challenges.

Industries

PharmaBiotechnologyClinical Research

Employee ratings

1,455 reviews

4.2/ 5

Culture

4.0

Career growth

3.5

Work-life

4.2

Employees rate it well for

Work Culture190Senior Management93Work Life Balance87Work Environment69HR Policies65

Find them on

Website LinkedIn AmbitionBox reviews

AHMEDABAD · FULLTIME

Sr Executive, QA Validation

Amneal Pharmaceuticals

Ahmedabad · onsite · Posted 40d ago

Sourced from Naukri

Undisclosed7–9 yrsfulltimeAhmedabad

About a minute. You'll make an account on the way through.

agent · working

Read this posting0.2s
Found the form on Naukri · 11 questions to answer1.1s
Decided the answers for all of them2.1s
Tailor your résumé to this role
Waiting for you

Section · 01

About this role

Key Responsibilities

To prepare and review of URS, DQ, QRM, FAT, SAT, and vendor/ supplier s documents related to qualification.
To execute Qualification / Re-Qualification and Validation activities of Equipment / System / Facility and Plant utilities (HVAC system, Autoclave, Isolator, Filling machine, Washing machine, Depyrogenation tunnel, UAFs, Packaging equipment, Water system, Pure steam generation and distribution system, Nitrogen/compressed air distribution system etc.).
To perform qualification activities like air flow visualization study, Temperature mapping of Rooms/Chambers, Packaging validation, Transport validation etc.
To co-ordinate with manufacturing, Engineering, Material Management, QC personnel and other users for respective Qualification / Validation / Re-qualification activities for timely completion of activities.
To prepare and review Validation/ Qualification protocols and reports (IOQ, PQ, RQ, CQ, other miscellaneous qualification documents etc).
To prepare and review process validation, cleaning validation, media fill and hold time study protocols and reports.
To prepare and review of SOPs of Validation and Quality Assurance Department.
To prepare and update Annual Validation Planner.
To prepare and execute project validation master plan for commissioning and qualification of new/modified facility.
To assess Change Control, Deviation, CAPA etc. and participate in investigation triggered through deviation, OOS, OOT or other failures.
To involved in QMS related activities i.e initiation and review of QMS elements.
To prepare, review and execute risk assessment activity related to equipment/ process/ facility/ system.
To conduct sampling activities as per the protocols (Hold time, Process validation and cleaning validation etc.).
Establish, monitor and maintain Validation function for audit readiness.
To prepare VMP and SMF.
To implement contamination control strategy at site.
Complete Validation Lifecycle: URS, DQ, FAT, SAT, Commissioning, IQ, OQ, PQ
End-to-end validation lifecycle (URS, DQ, FAT, SAT, Commissioning, IQ, OQ, PQ)
Qualification of equipment, utilities, and facilities in sterile injectable manufacturing environments
Process validation and cleaning validation including protocol and report preparation
Thermal validation systems and temperature mapping studies
Media fill validation principles and execution
Basic risk assessment techniques (FMEA approach)
Validation documentation management and report compilation
Use of validation management software and electronic documentation systems
Coordination and management of end-to-end qualification/validation activities

M.Sc./ B.Pharm/ M.Pharm with minimum 7-9 years of relevant experience
Hands-on experience in Qualification/Validation function within an injectable pharmaceutical manufacturing environment

Sourced from naukri

Section · 02

Skills

Section · Company

About Amneal Pharmaceuticals

Amneal Pharmaceuticals

Pharma

5.5k+

employees

2002

24 years old

Bridgewater, New Jersey

United States (USA)

About

Amneal Pharmaceuticals operates in the pharmaceutical sector, focusing on developing accessible and affordable medicines to address critical healthcare challenges.

Industries

PharmaBiotechnologyClinical Research

Employee ratings

1,455 reviews

4.2/ 5

Culture

4.0

Career growth

3.5

Work-life

4.2

Employees rate it well for

Work Culture190Senior Management93Work Life Balance87Work Environment69HR Policies65

Find them on

Website LinkedIn AmbitionBox reviews