| Job Description | Position: Manager- Quality & Regulatory Affairs
Experience: -8+ Years
Qualification: - M.Sc degree in Science (emphasis in microbiology biochemistry, molecular biology.
Location : Mumbai
Position Details
Responsible for developing and maintaining Quality systems with P2P partners. Help maintain quality of imported and finished products. Also responsible to meet the regulatory requirements of company Business
Task/Responsibilities:
• Manage and Monitor the Quality of incoming and outbound products from P2P partners
• Develop and implement SOP’s
• Drive improvements in Quality Excellence
• Work with P2P partners to implement the initial batch processes of new products and ensure proper quality is achieved. Coordinate internally help support this.
• Help company meet all regulatory requirements of the business. Set up systems and processes for long term implementation.
• Regular Audits of the toller site, improvement,& implementation of corrective actions.
• Attend Quality complaints at Customer’s place in co-ordination with Sales Team, Analyse , Provide solution with corrective actions planned at Manufacturing sites for formulations( RM,PM and Finished Products)
• Co-ordination in approvals of Packaging materials with Indian Institute of Packaging, Mumbai
• Developing standards of New formulations including Raw materials, execution of CPP to final products at toller sites
• Qualification & Regular audits of sites of manufacturers of Raw materials & Packaging materials
• Co-ordination with Global Team for implementation of Quality Management system at toller site
Education/Experience:-
- Msc degree in Sciences with emphasis in microbiology biochemistry, molecular biology.
- Minimum of 8-10 years of industry-specific experience in Quality & Regulatory department of a pharma or Disinfectant company
- Excellent articulation skills with the ability to communicate key technical concepts both verbally and in writing.
- Strong, customer-focused philosophy..
Please send across your cv. in word formats mentioning your present employer, location, and CTC and project experience.
The company is one of the best pay masters in the Industry.
Looking forward to communicate with you.
Kaushal Kumar
GlobalHunt India Pvt. Ltd
Direct:- 011-46547737
Board:- 011-46547700
GSM:- 09958492266
Email: jobs@globalhunt.in, kaushal@globalhunt.in
http://www.globalhunt.in
|
| Desired Profile | - Msc degree in Sciences, 8+years industry-specific experience in Quality & Regulatory department of a pharma or Disinfectant company
- Excellent communication skills & Strong, customer-focused philosophy.
|
| Experience | 8 - 13 Years |
| Industry Type | Pharma/ Biotech/Clinical Research |
| Role | QA/QC Mgr |
| Functional Area | Production, Maintenance, Quality |
| Education | UG - Any Graduate - Any Specialization,Graduation Not Required
PG - M.Sc - Any Specialization,M.Tech - Any Specialization |
| Location | Mumbai, Mumbai Suburbs |
| Keywords | Quality System, Regulator Affairs, Quality Excellence, Quality Management System, QMS, Process Improvement, Quality complaints |
| Contact | Kaushal Kumar
Global Hunt
E-45/6, Okhla Phase-II New Delhi
NEW DELHI,Delhi,India 110020 |
| Telephone | 91-11-46547737 |
| Email | jobs@globalhunt.in |
| Website | http://www.globalhunt.in |