Executive-Packaging & Device Development
Sun Pharmaceuticals, Inc, Indiana, PA, United States
Job Title:
Executive Packaging & Device Development
Business Unit:
R&D1 Regulatory Affairs
Job Grade:
G12A
Location:
Vadodara
Job Description
Characterization of RLD Pack samples for PFS, IV bags, Devices, Ophthalmic etc.
Finalization of pack configuration for exhibit batches of new generic products/ NDA products as per requirement.
Identification of new packaging materials and new vendor development for packaging materials.
Mold development for primary & secondary packaging materials and its validation.
Support to regulatory team for ANDAs / NDAs /EU filling for regulated market & support for query response.
Coordination with NPI and planning team for launch of product.
Preparation and review of Specification, MPC & FMEA, Pack style, Threshold Analysis, DHF compilation, GSPR and Technical Document preparation as per EU MDR requirements
Performing functional tests for injectable pack as per country requirements as defined in ISO/USP. Preparation of development study protocol, report and execute the study.
Support to plant for troubleshooting activities & market complaint.
Coordination with cross functional team like FDD/RA/Plant/PPIC/Marketing/BD/PMO for completion of task.
Travel Estimate NA
Job Requirements
Educational Qualification:
M. Pharm or PG from IIP
Experience:
0-2 years
Disclaimer The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
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Executive Packaging & Device Development
Business Unit:
R&D1 Regulatory Affairs
Job Grade:
G12A
Location:
Vadodara
Job Description
Characterization of RLD Pack samples for PFS, IV bags, Devices, Ophthalmic etc.
Finalization of pack configuration for exhibit batches of new generic products/ NDA products as per requirement.
Identification of new packaging materials and new vendor development for packaging materials.
Mold development for primary & secondary packaging materials and its validation.
Support to regulatory team for ANDAs / NDAs /EU filling for regulated market & support for query response.
Coordination with NPI and planning team for launch of product.
Preparation and review of Specification, MPC & FMEA, Pack style, Threshold Analysis, DHF compilation, GSPR and Technical Document preparation as per EU MDR requirements
Performing functional tests for injectable pack as per country requirements as defined in ISO/USP. Preparation of development study protocol, report and execute the study.
Support to plant for troubleshooting activities & market complaint.
Coordination with cross functional team like FDD/RA/Plant/PPIC/Marketing/BD/PMO for completion of task.
Travel Estimate NA
Job Requirements
Educational Qualification:
M. Pharm or PG from IIP
Experience:
0-2 years
Disclaimer The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
#J-18808-Ljbffr