Company
HLL Lifecare Limited, a Mini Ratna
Central Public Sector Enterprise under the Ministry of Health & Family
Welfare, Govt. of India is a global provider of high quality healthcare
products & services. With state-of-the-art manufacturing facilities
spanning across India, HLL is diversifying into vaccine manufacturing, lifecare
services, sanitary napkins besides engaging in procurement consultancy, healthcare
infrastructure development and facility management.
Qualification Experience:
Essential : 1 Year for deputy Manager and 3
years for Manager. Experience in FDA regulated environment, with experience in
USFDA, EU or MHRA audits
Desirable :
1) Experience in laboratory
practices, release of materials and products and conducting investigation.
2) Previous GMP system management experience.
3) Strong written and verbal
communication skills, specifically in technical writing communications and oral
presentations.
Responsibilities include:
1) Document Review & Approval
such as method validations, manufacturing records, and process or analytical
variances.
2) Approve and monitor corrective
& preventative actions.
3) Evaluates if there is any
quality impact to process/product and take appropriate action.
4) Review and approve Batch
records, SOPs, Change Controls, Validation Reports and Equipment Qualification
for Clinical trial materials.
5) Product Development and
Technical Services Support: Transfer projects to commercial production.
6) Communicate with Contract
Customers regarding quality related issues and Quality Agreements.
7) Prepare Product Development and
Technical Services for PAIs (Pre-Approval Inspections) for Clinical trial
manufacturing.
8) Industry Regulations: Stay
informed of cGMP trends, FDA and ICH guidelines with application to product
development.
9) Keep informed of product
transfer and methods transfer
10) Implement Quality Improvement
Projects as needed.
11) Support R&D and Product
Supply and provide assistance in project / technology / method transfer to
commercial QA/QC.
12) Participate in development of
GMP training program, on job documentation training for R&D personnel and
provide on-going GMP training to the R&D associates.
13) Prepare Quality Agreement with
new 3rd party / contract labs as required by the development team
