Responsibilities
1. Responsible for preparation and review of batch processing records.
2. Responsible for review & maintaining record of Standard operating procedure of Quality control and Standard testing procedure/GTP of FG/Intermediate/In-process/ Raw materials.
3. Responsible for preparation of Annual product quality review Fexofenadine Hydrochloride.
4. Responsible for handling & review of protocol & report of process validation/cleaning validation/drying validation/blending validation etc. Also responsible for assigning document control number as per VMP and compliance of SOP of process validation.
5. Responsible for handling of change control, deviations & incidents and assessment QRM.
6. Coordinating the investigation of out of specification of Intermediates/Raw Material.
7. Responsible for handling/compliance of reduced testing of API/Intermediate/RM as per SOP and maintaining schedule.
8. Responsible for batch review, preparation of product release checklist, checking of Labels & seals and weight verification of outgoing Intermediate/API.
9. Responsible for disposal of reverse sample as per SOP.
10. Responsible for review of analytical protocol of Finished Goods/Intermediates.
11. Responsible for fulfilling the requirement of regulatory affairs.
12. Responsible for issuance of logbooks.
13. To contribute towards achievement of departmental objectives on QMS (ISO 9001:2015)
14. Responsible for compliance to EMS & Safety related required as laid down for respective area.
15. To understand and participate in fulfilling compliance toward significant Environmental aspect and identified risk in respective area
16. To participate in awareness and training related to environment.
17. To contribute towards achievement of departmental objectives on EMS & Safety
18. To upkeep documents and records related to EMS.
19. To enhance awareness on EMS related to process in respective area which are carried out on routine basis
20. To participate in safety committee meetings conducted on regular basis
21. To remain committed toward prevention of pollution & zero accident & illness in respective area.
Experience
2 - 5 Years
No. of Openings
2
Education
Post Graduate (M.Pharma, M.Sc)
Role
Quality Assurance Executive
Industry Type
Pharma / BioTech / Clinical Research
Gender
Male
Age Limit
21 - 25 Yrs.
Job Country
India
Type of Job
Full Time
Work Location Type
Work from Office
Benefits include
Flexible Working Hours, Health Insurance, ESI, Food/Meals