http://my.monsterindia.com/create_account.html?job=15171120&from=indeed_moin&spl=IN_Indeed_new&WT.mc_n=olm_sk_IN_Indeed&spl=IN_indeed_april&WT.mc_n=olm_sk_feed_indeed_IN&gd=1
- Company Name: Sai Tecnico Solutions
- Location: Ahmedabad, Baroda
- Experience: 4 - 10 Years
- Keywords / Skills: SOPs, Validation, Product specification, COAs
- Function: Pharmaceutical/ Biotechnology
- Role: Regulatory Affairs Executive,Regulatory Affairs Manager
- Industry: Pharmaceutical
- Posted On: 15th May 2014
About Company
We are established in the field of recruitment & manpower providers for the past Three Years. During all these years we have successfully catered & provided requisite manpower requirement of various Companies in India to their entire satisfaction since we are a one- source multi-resources organization. We have provided our services to the critical core industries i.e. Chemical, Pharmaceutical, Engineering, Automobile, Construction, Cement/Metal, Trading, IT, Education, BPO & Other service sectors.
Job Description
Job Responsibilities:
1. Preparation of registration dossiers for countries suggested by Senior Management.
2. Review of adequacy of dossier as per country specific regulations.
3. Response to queries raised by the Regulatory Authorities.
4. Response to technical queries of the Notified Bodies.
5. Response to technical queries of customers/consultants.
6. Preparing the strategy for the entry in any country.
8. Allocating and reviewing job of team members for timely completion of activities.
9. Supporting to QA for various activities like preparation of SOPs, Validation, Product specification, COAs etc.
10. Participate in the product development activities by providing the information to the Design and Production team for the product compliance in the development phase.
11. Ensuring the product development activities lead to a regulatory approvable product.
12. Working on the Plant Layout for Plant up-gradation.
13. Working on bringing new system of documentation and control in the Plant to better compliance to laws and to reduce the rework quantum.
14. Searching the consultants for entry in to any international market. Finalization of the terms and condition of working with the consultants.
15. Providing information to various people in all the concerned departments on new regulations and changes in the existing regulations.
16. Ensuring Label compliance as per the specific country Regulations.
17. Facing audits of the Notified Body and Local FDA personnel.
18. Working on the development of system to establish the finished product validation condition, criteria (through various virtual and mechanical testing) so that Sharma can shelf dependent on this activity.
19. Informing and ensuring senior management on various regulatory requirements on outsourcing any critical activity to the vendors like Casting, Coating, Sterilization etc.
20. Performing any activity suggested by the senior management.
Please send me your resume on rect3 @ saigroupbrd.com
1. Preparation of registration dossiers for countries suggested by Senior Management.
2. Review of adequacy of dossier as per country specific regulations.
3. Response to queries raised by the Regulatory Authorities.
4. Response to technical queries of the Notified Bodies.
5. Response to technical queries of customers/consultants.
6. Preparing the strategy for the entry in any country.
8. Allocating and reviewing job of team members for timely completion of activities.
9. Supporting to QA for various activities like preparation of SOPs, Validation, Product specification, COAs etc.
10. Participate in the product development activities by providing the information to the Design and Production team for the product compliance in the development phase.
11. Ensuring the product development activities lead to a regulatory approvable product.
12. Working on the Plant Layout for Plant up-gradation.
13. Working on bringing new system of documentation and control in the Plant to better compliance to laws and to reduce the rework quantum.
14. Searching the consultants for entry in to any international market. Finalization of the terms and condition of working with the consultants.
15. Providing information to various people in all the concerned departments on new regulations and changes in the existing regulations.
16. Ensuring Label compliance as per the specific country Regulations.
17. Facing audits of the Notified Body and Local FDA personnel.
18. Working on the development of system to establish the finished product validation condition, criteria (through various virtual and mechanical testing) so that Sharma can shelf dependent on this activity.
19. Informing and ensuring senior management on various regulatory requirements on outsourcing any critical activity to the vendors like Casting, Coating, Sterilization etc.
20. Performing any activity suggested by the senior management.
Please send me your resume on rect3 @ saigroupbrd.com
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