Sr. GMP Consultant

Job Title:

Location:

Position Type:

Education

Job Requirements:

a)15-18 years of experience in Sterile manufacturing facility.

b) Strong understanding of Sterile product manufacturing, vaccine / biologicals product manufacturing, testing and regulatory requirements

c) Preferred candidates: Regulatory exposure working in Quality Assurance, Audits & Compliance in Sterile product manufacturing, vaccine / biologicals product manufacturing. Should be thorough with QA reqts wrt QMS, handling Greenfield projects, Qualification & Validations – Equipment , Utilities, cleaning validation , process validation etc. Persons having exposure facing regulatory inspections at leading role. Experience participating in or leading EU GMP inspections, MHRA, USFDA inspections.    

d)  In-depth knowledge of EU GMP regulations including Annex 1 and other relevant guidelines.

e) Job profile involves extensive travelling domestic & International.

f)  Good Personality & Etiquettes , fluency in English both verbal & written is must.

g) Person should be willing to relocate in or around Navi Mumbai