Candidate should be FDA approved
QUALIFICATION: B.. PHARMA/B.Sc/M.Sc/
EXPERIENCE: 2 TO 5 YEARS IN API PHARMACEUTICAL
Job Profile
1.Preparation and review of specification and standard test procedures of Raw materials, In-process, finished products and stability study.
2.Daily planning of samples.
3.Literature search and DMF review of new projects.
4.To prepare the Standard Operating Procedures.
5.To prepare the method validation protocols and reports.
6.To develop the all the required methods and validate it partially
7.To transfer the technology of the developed analytical methods to the quality control laboratory by doing the method validation jointly with quality control chemist.
8.To help to solve the regulatory querries.
9.To coordinate with service engineer in case of break down of the instrument.
10.To co-ordinate with other department.
11.To get the quotation from vendors and prepare the PO accordingly.
12.To plan and review the stability samples as per the schedule.
13.To review log books of instruments.
14.To review and maintain HPLC column inwarding records.
15.To review analytical data of In-process, Finished products, Stability samples, Partial Method validation/ verification.
16.To review calibration records of instruments.
17.Management of reference standards and working standards.
18.To discard the samples after completion of analysis as per the procedure
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