Quality Assurance Executive

Orex Pharma Pvt. Ltd.

Job description

Preparation, review and issue of finished product specifications for new / repeat commercial orders.

Preparation, review and issue of finished product certificate of analysis to logistics dept. for commercial orders.

Preparation and review of reports for in-process quality checks (semi-finished and finished samples) and co-ordination with logistics dept. / Mfg. unit for compliance/non-compliance of the products.

Checking/proof-reading of artworks for commercial orders received from DTP team.

Checking/proof-reading of pre-printing proof / packing material control samples / shade cards received from printers and co-ordination with logistics team for compliance/non-compliance of the artworks/packing materials.

Maintenance of track records of all commercial orders including artwork approval activities and approval of semi-finished and finished samples.

Co-ordination with Mfg. units for issue of product codes, batch details, Bar Codes (for third party products) and documentation (including raw materials specifications and MOAs, finished product specifications and MOAs, QQ formula, finished product COAs).

Co-ordination and follow-up with Mfg. units for market complaints and procurement of fresh samples for registered or under-registration products.

Responsible for identification and trouble-shooting of mfg. defects in finished products and/or raw materials and packing materials.

Co-ordination with buyers for approval of artworks / for supportive regulatory documentation for renewal / amendments of CPRs.

Co-ordination with organizational depts. (regulatory, marketing and logistics dept.) for product quality assurance.

Co-ordination with independent approved drug testing laboratories for analysis of products and follow-up for lab. Reports.

Miscellaneous activities including assistance to regulatory team in preparation of product labelling (product insert / SPC / PIL), raw materials (active and inactive) specifications, MOAs and COAs, packin

• Experience3 - 6 Years
• No. of Openings01
• EducationB.Pharma, B.Sc, M.Sc
• RoleQuality Assurance Executive
• Industry TypeManufacturing / Production / Quality
• GenderFemale
• Job CountryIndia
• Job TypeWork from Office