Vadodara
1 hour ago
16 Applied
JOB ID:163776
Job Type
Returnee Program
Functional Area
General Management
Industry
Pharma/Biotech/Clinical Research
Education
Not Specified
Experience Required
9 - 15 Yrs
Key Skills Required
mpc & fmea, new vendor development, anda’s/nda’s filling
Other Skills Required
Job Description
Education : Graduate / PG Dip in Packaging Development from IIP
Department : R&D Packaging Development
Experience : 9 to 15 years in R&D Packaging Development
1. Characterization of RLD pack samples
2. Finalization of packing configuration for Exhibit batch packing of new generic product/NDA as per requirement
3. Identification of new packaging material & new vendor development for packaging material
4. Mold development for primary packaging material & secondary packaging material & its validation.
5. Support to Regulatory team on ANDA’s/NDA’s filling for regulated market
6. Coordination with NPI & planning team for launch of ANDA’s/NDA’s
7. Preparation & revision of packaging material specification
8. Preparation & review of MPC & FMEA
9. Preparation & review of Development Study protocol & report & execute the study.
10. Performing functional test as per country requirement
11. Coordination with Cross functional team like FDD/RA/Plant/PPIC/Marketing/BD/PMO for completion of task
12. Participating i
... See MoreEducation : Graduate / PG Dip in Packaging Development from IIP
Department : R&D Packaging Development
Experience : 9 to 15 years in R&D Packaging Development
1. Characterization of RLD pack samples
2. Finalization of packing configuration for Exhibit batch packing of new generic product/NDA as per requirement
3. Identification of new packaging material & new vendor development for packaging material
4. Mold development for primary packaging material & secondary packaging material & its validation.
5. Support to Regulatory team on ANDA’s/NDA’s filling for regulated market
6. Coordination with NPI & planning team for launch of ANDA’s/NDA’s
7. Preparation & revision of packaging material specification
8. Preparation & review of MPC & FMEA
9. Preparation & review of Development Study protocol & report & execute the study.
10. Performing functional test as per country requirement
11. Coordination with Cross functional team like FDD/RA/Plant/PPIC/Marketing/BD/PMO for completion of task
12. Participating in FAT of machines
13. Handling of Medical Devices, injectable and characterization.
14. Preparation of Threshold Analysis and URRA.
15. Support to plant for validation & trouble shooting activities
16. Support to plant for market complaints
17. Preparation of Packaging documentation like Pack Style, Justification Report etc. as per Product/Regulatory requirements See Less
Sun Pharmaceutical Industries Ltd. (Sun Pharma) is the fourth largest specialty generic pharmaceutical company in the world with global revenues of over US$ 5.1 billion. Supported by more than 40 manufacturing facilities, we provide high-quality, affordable medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe.
