JOB DESCRIPTION:-

POSITION #1

Review of analytical data like test method validation, stability reports, standard operating procedures, standard test procedures, analytical protocols, stability protocols.

Review of batch manufacturing records, product development reports.

Able to handle change control, CAPA, Market complaints. Review of tech transfer documents, developmental reports. Able to conduct audits in analytical, packaging, microbiology,

clinical, third party manufacturing etc. Establishing, implementing and maintaining quality systems and

allied documentations. Expert in preparation of technical reports, audit reports.

Position#2&3

1)Draft and review of SOP,s, specifications, standard test procedures, R&D sections of regulatory submissions. Stability data, annual product review report.

2)Ensure data review of qualification, calibration and maintenance of analytical equipment’s, stability chambers.

3) Ensure Compliance to GMP, Safety procedure in lab. 4)Ensure thorough knowledge of manufacturing plant c

GMP/operations/procedures. 5) Review of process validation, cleaning validation, equipment

validation, method validation plans. Protocols, batch manufacturing data archival, review and incident

report. 6) Well versed with BMR, MFR, pilot plant, scale-up , tech transfer

activities. 7) Familiar with SUPAC, ANDA, and ICH guidelines. 8) Hands on experience of personal care, topical care , food and

nutritional products, herbal products would be an added advantage.

NOTE:-

1) Along with above qualification candidate should have good communication skills, should have command over English both written and oral.

2)Good computer skills, as MS-OFFICE,MS-WORD,MS EXCEL, POWER POINT, internet etc.

3) Knowing LIMS,ETQ,QMS and compliance software would be an added advantage.

Page 1 of 2