Assistant Manager

Umedica Labs

8 - 12 years

7 - 10 Lacs

navi mumbai mumbai (all areas)

Posted:3 days ago| Platform:

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Skills Required

development quality assurance mfr pdr document review

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities

Handling Formulation Documentation as per Regulatory/Quality Requirements
Prepare Finished Products & Stability Specification, STP for Different Formulation.
Document Review in formulation :- PDR, BPR, BMR,MFR etc.
Daily QA rounding in R&D (ADL, FRD & BRD) lab
To prepare in-process, finished product and stability specification and standard test procedures for regulator (US/EU & Canada) market for solid dosage formulations.
To revise QA SOP when periodic revision and Getting follow-ups for revision of due Sops
Issuance, Distribution, Control and Accountability of Quality documents like formats, R&D specifications SOPs.
To provide induction for new employee and maintain training record file of new employees.
Monitoring of GMP, GLP and Calibration related activities in analytical and formulation department.
To handling license related queries application for R&D.
To review change control related R&D specification.

Preferred candidate profile

Educational Qualification:

MSc /M. Pharm

Work Experience:

8-10 Years

Location

Mumbai based or ready to relocate.

Interested candidates can share their CV's on vaishnavi.k@umedicalabs.com

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