Abbott India Limited is a subsidiary of Abbott Laboratories, USA, a global, iversified health care company devoted to the discovery, development, manufacture and marketing of pharmaceutical, diagnostic, nutritional and hospital products. The company now employs approximately 70,000 people and markets its products in 130 countries worldwide.
Post: SENIOR CLINICAL QUALITY ASSOCIATE - AVD-12000001SF
Job Description:
Responsible for supporting CR staff globally in ensuring compliance with company policies and procedures and GCP regulations/guidelines and any other applicable requirements.
Compliance & Training Support
•Advises CR staff on GCP guidelines, ISO Standards and departmental procedures
•Facilitates departmental trainings.
•Coordinates internal continuous improvement detection (CID) and CAPA handling, including approval of actions proposed and follow-up until closure.
•Drives continuous improvement processes.
Clinical Study Support
•Act as a reviewer of protocols, informed consent forms, case report forms and other essential study documentation for product and process changes, offer overall support to project teams in order to eliminate compliance risks.
•Represents Clinical Quality at project / protocol deviation meetings to maintain and promote quality and compliance within CR.
Audit Support
•Key player in the preparation and overall support for internal/external audits including responding to audit findings on behalf of the organization.
•Performs pro-active internal compliance assessments.
•Supports project teams should investigational sites need support in preparing for an AQR audit or an authority inspection.
•As assigned: Manages the Supplier Qualification program, including organization of audits and follow up of supplier CAPAs.
Clinical Regulatory Support
•As assigned: Owner of the Regulations database, coordinator role to obtain, interpret and communicate regulatory requirements.
•Serves as a liaison between CR and TEM Regulatory and TEM QA.
Candidate Profile:
•Job/Technical Knowledge: strong understanding of GCPs, Quality Assurance/Control, as well as of relevant regulations and procedures.
•Cooperation/Teamwork:team player with autonomy capable of working independently under minimal supervision.
•Planning and organizational skills: Organizes self in an efficient manner:
•Problem solving: gathers information before making decisions; weighs alternatives against objectives and arrives at reasonable decisions.
•Adaptability: remains open-minded; performs a wide variety of tasks and changes focus quickly as demands change.
•Initiative / Innovation:; explores alternative successful ways of working and tools; able to challenge conventional practices;; creates novel solutions to problems.
at least 3 years of related work experience in Quality role in medical device area and/or clinical trial environment. Preferably GCP audit experience.
Education Requirements Bachelor Degree (Preferably in Science)
Additional Information:
Location: Mumabai, Maharashtra
Industry Type: Pharma / Biotech / Clinical Research
Functional Area: CR
Last Date: 13th Feb, 2013
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