Haridwar, Uttarakhand, India
Not disclosed
On-site
Full Time
requirements persons in PRODUCTION/INJECTION Section. PRODUCTION/INJECTION:- EXPERIENCE- 08 to 10 YearsQUALIFICATION- B.PHARM/M.PHARMSALARY - Best for right CandidatesDESIGNATION- SR. OFFICER/ASSISTANT EXECUTIVEREQUIREMENTS – 02 PERSONRESPONSIBILITIES-To check dispensing of raw materials and primary packing materials.Online documentation and timely entry related to production operation and activity.Housekeeping and cleanliness, and adherence to personal hygiene requirements of working personnel.Completion of BMR and summation of department head.To ensure the batch manufacturing records and other documentation work are maintained as SOP.To carry out all production process as per SOP.To ensure the load preparation, washing, filling & sealing according to SOP.Co-ordination with other departments regarding production activities.Timely reporting of activities & process to Sr. staff.To ensure the monitoring & records of temperature, relative humidity & differential pressures.To ensure & record of cleaning of classified area and aseptic areas.Ensuring maintenance of BMR and all other relevant records.Control and review of rejection incurred at each stage, achievement of capacity output & cost control.Production planning, material requirements workout/stock position,Handling of SAP systemTo do batch manufacturing as per daily plan.Email resume at training@pilindia.in
Haridwar, Uttarakhand, India
None Not disclosed
On-site
Full Time
About the Job.: Support RA Team and contribution in regulatory activities in order to achieve the objective of the department. Key Accountabilities.: 1. Global Product registration 2. Lifecycle management of the registered products 3. Compilation and update of dossiers for ROW market 4. Arrange and review CMC data required for dossier preparation. 5. Arrange documents of variation applications whenever required. 6. Assist in the co-ordination of response to the queries raised by Regulatory Authorities. 7. Coordinate with internal departments for documents and sample arrangement. 8. Prepare Product Questionnaire 9. Prepare and review the Draft Artwork, SMPC and PIL as per Country specific Regulatory guidelines & client requirements 10. Keeping updated information of relevant new/draft regulation/guidelines of global Regulatory Authorities including post approval requirements. 11. Prepare applications for legal documents-Product Approval, CoPP, FSC, renewal of WHO GMP & Mfg. Licenses. 12. Update all regulatory data related to activities to ensure RA workplan and Market Authorization database up to date. 13. Strong Listening and communication skills are required. Experience.: Having 4-5 years of experience in Regulatory affairs.
Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.
We have sent an OTP to your contact. Please enter it below to verify.