National Accreditation Board for Testing & Calibration Laboratories (NABL) is an autonomous society providing Accreditation (Recognition) of Technical competence of a testing, calibration, medical laboratory & Proficiency testing provider (PTP) & Reference Material Producer (RMP) for a specific scope
Friday, 2 November 2018
Piramal Enterprises Ltd - Walk-In Interviews for QC-Executives on 27th Oct & 4th Nov' 2018
Walk-In for QC-Executive @ Piramal Enterprises Ltd
Department: Quality Control
Position: Executive
Experience: 3 – 6 years with Handling Experience on HPLC, GC
Qualification: B.Pharm / M.Pharm
Date & Time: Saturday (27.10.2018) & Sunday (04.11.2018) between 10 AM to 2 PM.
Please do not forward resume
Venue:
Piramal Enterprises Limited
Plot # 67-70, Sector 2,
District: Dhar, Pithampur,
Madhya Pradesh 454 775
India
Plot # 67-70, Sector 2,
District: Dhar, Pithampur,
Madhya Pradesh 454 775
India
Wednesday, 31 October 2018
BIOCLINICA - Freshers & Experienced Walk-In @ Bangalore near Basavanagudi on 3rd Nov' 2018
Walk-In for Freshers & Experienced @ our Bangalore office on 3rd Nov, 2018 (Saturday)
This role is into Pharmacovigilance domain and the walk-In timings are in between 9 AM – 1 PM.
Walk-In Venue:
Bioclinica India Pvt. Ltd,
#18/2 & 18/3, V G Heritage,
Vanivilas road,
Basavanagudi,
Bangalore.
Kindly go through the job description and walk-in with your updated resume.
JOB TITLE: Drug Safety Associate
LOCATION: Mysore, India
YEARS OF EXPERIENCE: 0 to 2 years
EDUCATION: Any Health care professional (BPharm/M Pharm/ Pharm D/B. Sc Nursing / BPT / BDS / BHMS / BAMS etc.)
Essential Duties and Responsibilities:
As Case Intake Member:
· Responsible for case intake, duplicate check, and registration
· Maintain log of source documents and other communications
As Case Processor:
· Responsible for data entry of individual case safety reports into the safety database.
· Review and evaluate AE case information to determine required action based on and following internal policies and procedures
· Process all incoming cases in order to meet timelines
· Full data entry including medical coding and safety narrative
As Medical Coder
Responsible for coding all medical history, events, drugs /procedures/indications and laboratory tests according to the appropriate dictionary (For e.g. MedDRA, Company Product Dictionary, WHO-DD)
As Narrative Writer
Responsible for writing medically relevant safety narrative of cases and checking the completeness and accuracy of the data entered in the various fields.
As Literature Review Specialist
· Ensure effective and accurate collection, recording, review and reporting of literature searches conducted.
· Review of literature articles to identify case safety reports.
· Responsible for operational Pharmacovigilance activities for assigned developmental and/or marketed products.
· Assist in signal generation and safety analysis activities.
· Ensure quality of literature searches and reporting.
· Review of local/global literature reports to determine regional reportability.
· Create/maintain study summary documents.
· Assist with narrative writing for periodic/ad hoc submissions.
· Assist with ad hoc or routine safety monitoring activities.
Other Responsibilities:
· Following up with sites regarding outstanding queries.
· Follow up on reconciliation of discrepancies.
· Follow departmental AE workflow procedures
· Closure and deletion of cases
· Perform any other drug safety related activities as assigned
· Perform literature review activities when trained and assigned.
Specialized knowledge and skills:
· Basic competence with medical and therapeutic terminology.
· Ability to work independently but guided by documented procedures, with appropriate support.
· Able to work effectively as part of a team.
· Understanding of patient safety regulatory obligations.
· Should be familiar regulatory &pharmacovigilance guidelines.
· Should be familiar with pharmacovigilance terminology.
· Excellent attention to detail.
· Ability to deliver within established timelines.
· Fluency in English and excellent comprehension.
· Computer literate.
Communication Skills:
Requires a proactive approach and excellent written/oral communication and interpersonal skills. Strong interpersonal skills required to interact with clients, management, and peers effectively. Effective cross- department communication. Ability to document and communicate problem/resolution and information/action plans.
Requires a proactive approach and excellent written/oral communication and interpersonal skills. Strong interpersonal skills required to interact with clients, management, and peers effectively. Effective cross- department communication. Ability to document and communicate problem/resolution and information/action plans.
Desired technical skills:
Person should be familiar with MS Office Tools.
Safety database knowledge.
Other skills:
The ability to contribute to a team environment with a high degree of professionalism and skill. Demonstrate flexibility within a dynamic, fast-paced, cross-functional team. Demonstrated ability to complete multiple tasks concurrently and deliver results in a fast-paced environment. Ability to perform under stringent timelines.
Compliance:
Awareness of organizational policies & procedures governing his/her job responsibilities. Awareness and compliance of QMS & ISMS policies & procedures and their impact at his/her job level. Should understand escalation matrix and escalate to the next level whenever incidents happen which are not in compliance with organizational, QMS & ISMS policies and procedures.
Working Conditions: Normal office environment.
Hours:
Standard Hours 40 hours per week, one-hour lunch, Monday – Friday.
Additional hours as needed.
Willing to work in shifts as and when needed
Enaltec Labs Pvt. Ltd - Walk-Ins interview in Near Ambernath on 2nd & 3rd Nov' 2018 for AMV & QC - Microbiology
Date & Time: 2nd November - 3rd November, 10 AM onwards
Venue: Enaltec Labs Pvt. Ltd.
Plot No: W18, Anand Nagar,
MIDC, Ambernath(E) ,
Thane - 421506, India
Department: Analytical Method Validation
1) The candidate should have the experience of AMV of the drug product and drug substance
2) The candidate should have the experience 2 to 5 years in above-mentioned activity.
3) The candidate should have the knowledge/experience in cGMP and cGLP.
4) The candidate should have the exposure on online Chromeleon software more preferable.
5) The candidate should be well versed in the calibration of instruments like HPLC/UV/Dissolution tester/GC.
6) The candidate should have exposure in AMV protocol and report preparation.
2) The candidate should have the experience 2 to 5 years in above-mentioned activity.
3) The candidate should have the knowledge/experience in cGMP and cGLP.
4) The candidate should have the exposure on online Chromeleon software more preferable.
5) The candidate should be well versed in the calibration of instruments like HPLC/UV/Dissolution tester/GC.
6) The candidate should have exposure in AMV protocol and report preparation.
Interested Candidate can share their profile on neha.tiwari@enaltec.com
Department: Quality Control (Microbiology)
Designation: Executive / Sr. Executive - Microbiology
Designation: Executive / Sr. Executive - Microbiology
Total years of relevant industry experience: 3 to 8 years
Qualification: M.Sc. Microbiology
Qualification: M.Sc. Microbiology
· To maintain good microbiology practices in the lab.
· Preparation of Microbiology documents.
· To perform calibration, validation & performance qualification of microbiology testing equipment & instruments.
· Review of all analytical test records in Microbiology.
· Training of other staff of Microbiology department as per requirement.
· Sampling and analysis of the finished product.
· Sampling and testing of Purified water.
· Preparation and sterilization of culture media.
· Decontamination of culture media.
· To ensure cleaning of Microbiology lab and updating of the record.
· Fumigation in Microbiology area.
· Environmental monitoring by active and passive air sampling.
· Growth promotion test for microbiology culture media.
· Water analysis and trending.
· MLT optimization and validation.
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