Clinical Informatics Jobs Opening in Tevapharm India Pvt. Ltd. at Mumbai
FEATURED JOBclinical quality
organization.
Job Description
Responsibilities: § Audit BA/BE studies (both pre and post study) to assure the management that the facilities, personnel, equipment, instruments, protocols, methods, practice, records and controls are in conformance with the relevant and current GCP / applicable GLP guidelines, protocols and SOPs implemented as per SOP. § To control and issue the documents i.e. SOPs, forms, formats, log books, study specific protocols, validation protocols, qualification protocols of all departments of BEC site as per SOP. § Prepare audit report to adhere with the guidelines, written procedures and regulatory inspections and ensure compliance from user department to audit reports. § Conduct the in-process, retrospective audits of clinical phase of study in order to ensure the compliance to GCP/GLP, Protocols, SOPs and applicable regulatory requirements as and when study is assigned. § Review and audit medical screening records, case record forms, ICFs and other raw data generated during conduct of clinical study as per SOP. § To audit the SDTM data of clinical studies for regulatory submissions. § To audit Biosummary tables (OGD), eCTD compilation of clinical studies as per assignment. § To share the pharmacokinetic sampling sheets of respective studies to the Biostatistician. § Review ICF audio visual recording of participated and non-participated subjects of all clinical studies as and when study is assigned. § Review clinical study report to ensure that the report is in accordance with SOPs, protocol and applicable regulatory requirements and that the reported results accurately reflect raw data of the clinical studies as per SOP. § Conduct the general audit and system audit as per SOP. § Review of Instruments/Equipment/Software Qualification, Calibration and Validation records as per SOP. § To carry out other responsibilities as and when assigned by the Head clinical QA
Job Particulars
About Company
Mumbai 
Freshers 
Salary not disclosed 
BSc(Zoology / Applied Zoology)
Mumbai
1 to 3+ Years
Salary not disclosed
BSc
Ahmednagar, Aurangabad, Jalgaon, Kolhapur, Mumbai, Nagpur, Nashik, Pune, Solapur, Akola, Nanded, Amravati, Parbhani, Dhule, Latur, Bhiwandi, Malegaon, Maharashtra, Chandrapur, Khopoli, Ratnagiri, Beed, Bhandara, Buldhana, Gadchiroli, Gondia, Hingoli, Jalna, Nandurbar, Osmanabad, Palghar, Sangli, Satara, Sindhudurg, Wardha, Washim, Yavatmal, Thane, Raigad
1 to 5 Years
Salary not disclosed
Diploma
Mumbai
1 to 2 Years
Salary not disclosed
BSc(Biology, Zoology / Applied Zoology, Environmental Science, Veterinary Science), MSc(Biology, Zoology / Applied Zoology) 
