MANPOWER REQUIREMENT WITH QUALIFICATION/ EXPERTISE
Sr. No.
Section
No. of analysts
QUALIFICATION AND EXPERIENCE
1
API Finished products
6
· Candidate must hold M.Sc.(Chemistry)/equivalent qualification with good communication/presentation skill.
· He/ she should have hands on experience of 3-4 years in analysis of API and Intermediates with respect to modern analytical techniques like chromatography i.e. HPLC, GC in Quality control laboratory (QC) from the reputed organisation.
· Suitable candidate must have core experience in troubleshooting during chromatographic HPLC, GC analysis.
· Candidate must have operating knowledge of handling instruments i.e. XRPD, Karl fisher, Potentiometer, Polarimeter, IR, UV, Laser PSD, Coulometer etc. and knowledge on documentation as per cGMP.
· Candidate must be having awareness on good laboratory practices and Data integrity subjects and familiar with regulatory requirements and different guidelines like MHRA, USFDA, WHO, TGA etc. and having adequate knowledge of software i.e. LIMS, Chromeleon, track wise etc. will be preferred.
2
Process/cleaning validation
3
· Candidate should hold M.Sc.(Chemistry)/equivalent qualification with good communication/presentation skill.
· He/ she should have hands on experience of 3-4 years in analysis of API and Intermediates with respect to modern analytical techniques like chromatography i.e. HPLC, GC and other instruments i.e. Karl fisher, Loss on drying, Laser PSD etc. in Quality control laboratory (QC) from the reputed organisation.
· He/she should have knowledge and awareness of importance of process /cleaning validation.
· Candidate should have good knowledge on documentation as per cGMP and ICH guidelines.
· Candidate having knowledge of software LIMS, Chromoleon etc. will be preferred.
3
Raw materials
3
· Candidate should hold M.Sc.(Chemistry)/equivalent qualification with good communication/presentation skill.
· He/ she should have hands on experience of 2-3 years in analysis of Raw materials with respect to modern analytical techniques like chromatography i.e. HPLC, GC and other instruments i.e. Karl fisher, Polarimeter, Loss on drying and other classical analysis in Quality control laboratory (QC) from the reputed organisation.
· Candidate should have good knowledge on documentation as per cGMP and ICH guidelines.
· Candidate having knowledge of software LIMS, Chromeleon, track wise etc. will be preferred.
4
In-process testing
3
· Candidate should hold M.Sc.(Chemistry)/equivalent qualification with good communication/presentation skill.
· He/ she should have hands on experience of 3-4 years in analysis of API, Intermediates and/or In-process testing with respect to modern analytical techniques like chromatography i.e. HPLC, GC and other instruments i.e. Karl fisher, Loss on drying, Laser PSD and other classical analysis in Quality control laboratory (QC) from the reputed organisation.
· Candidate should have good knowledge on documentation as per cGMP and ICH guidelines.
· He/She should be taking independent decision after in-process analysis.
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