Biological E Ltd is a leading global vaccine & pharmaceutical company which provides affordable immunization and medicines across the world. It has current turnover of around Rs.1100 crore and employee strength of around 2000. It is growing at around 36% CAGR. Its intellectual pool of experienced scientist are based out of India and France. BE has state-of-the-art manufacturing sites in India (Hyderabad and Dehradun).
Post : Development Quality Assurance
Job responsibilities
● Preparation and review of QA SOPS and other documentation
● Compliance of product specifications and test procedures against applicable guidance documents
● Approval of method qualification protocols
● Coordination with respective development teams for material requirements
● Approval of specifications with vendor qualification activities
● Review of facility or utility monitoring
● Responsible for compliance of GMP during clinical trials
● Coordination with cross functional teams for submission of samples for various studies
● Review of documents for regulatory dossiersle
● Approval of protocols related to process and testing
● Approval of layouts qualification protocols of facility and equipment
● Approval of Batch Production Records.
Internal : QA, R&D, tech. dev, project management, RA, and other functional experts.
External : Vendors, Regulatory agencies, partners, experts
Technical Requirements : Knowledge on development of different vaccines, knowledge on clinical studies, documentation control management
Key personal competencies : Team management, good communication skills, presentation skills, problem solving skills, and decision making and critical thinking.
Additional Information:
Location: Shameerpet (Hyderabad)
Education: M.Sc Life Sciences
Industry Type: Pharma/ Biotech/Clinical Research
End Date: 10st September, 2017
Interested candidates can send in their resumes to Careers@biologicale.co.in
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