Job Location

　　Mumbai

　　Job Description

　　Description of role:

　　For this position we are looking out for the candidate will be responsible for various analytical technology transfers from development laboratory to the manufacturing sites at various locations across India. This includes tech transfer before actual manufacturing and also supporting formulation team during manufacturing of 1st three validation batches. They will be responsible for analysis of stability samples of these batches kept for incubation at various conditions as per ICH guidelines. They should be a good team leader and should have problem solving ability. The job description may require frequent traveling during technology transfers. Good communication skill with written and spoken English is a must.

　　Key accountabilities:

　　You will be responsible to support the Formulation Development for finalizing raw material specifications, analytical method verification and it’s validation. The validation shall be performed as per ICH guidelines and as per various Pharmacopoeia.

　　You will be responsible for analysis of stability samples of various products as per ICH/ WHO guidelines as a part of regulatory requirements hence knowledge of ICH guidelines on stability studies is required.

　　You will be responsible for performing analysis of various actives / inactive raw materials as per In-house methods or methods specified in various Pharmacopoeia like Indian Pharmacopoeia, British / European Pharmacopoeia, United states Pharmacopoeia and Japanese Pharmacopoeia. Hence he / she should have thorough knowledge of various general methods adopted in Pharmacopeia like System suitability criteria, elemental analysis, identification, titrimetric analysis etc.

　　You will be responsible for performing analysis of various finished products such as tablets, hard gelatin capsules, soft gelatin capsules, injections, syrups, creams, powder etc. the analysis shall be performed using various instruments like High performance liquid chromatography, Gas chromatography, UV VIS spectrophotometer, Autotitrator, Karl Fischer, Dissolution tester, Fourier transferred Infrared spectrophotometer, Polarimeter, Refractometer, Viscometer.

　　You will be responsible for calibration of various laboratory instruments which are used in various analysis like HPLC, GC, Dissolution tester, Disintegration testers, polarimeter, Refractometers. Drying ovens, Autotitrator, Karl fischer, Analytical Balances, FTIR, UV VIS Spectrophotometer, etc;

　　You will responsible for laboratory investigations during handling of Out of Specification(OOS); Out Of Trend(OOT); Deviations taken during various analysis.

　　You will be responsible for documentation as per Good Laboratory practice which includes maintenance of log books for various instruments, column history, records of working standards / reference standards / primary standards, labelling etc.

　　Additional knowledge in documentation system like VEEVA; Enovia will be appreciated.

　　Desired skills and experiences:

　　Should be with Positive attitude, result oriented, competent and a good team-player with a customer focus mindset

　　Should have Excellent communication and presentation skills, both oral and written English. Should have good computer knowledge to work in excel and word for documentation.

　　Should have Good Project Management and Planning & Organizing skills

　　Should have knowledge of various Pharmacopoeia like IP/BP/USP, ICH guidelines on stability, validation and quality risk Management.

　　Job Qualifications

　　M.Sc. Chemistry (like Organic chemistry, Inorganic chemistry, Physical chemistry, analytical chemistry) / B.Pharm

　　3 – 6 year experience in analytical method development or in Quality control with all skills as mentioned above.

　　Job Schedule

　　Full time

　　Job Number

　　R000096901

　　Job Segmentation

　　Experienced Professionals (Job Segmentation)

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