Covidien and Medtronic are committed to improving the lives of patients through ground-breaking medical technologies. By bringing our companies together, we are able to expedite our ability to create the meaningful innovations and therapies that fuel our mission to improve patients’ lives. This partnership will create new opportunities for skilled, ambitious people to change the way we work, and ultimately deliver better health for more people.
Post: Assistant Manager Quality Assurance and EHS - (1500088H)
Job Description
Main Purpose:
Responsible for establishment & implementation of robust Post-market surveillance Quality systems in Medtronic. Also responsible for ensuring that effective Quality Assurance and EHS Systems, programs and processes are in place.
Key Accountabilities:
QUALITY
- Responsible for implementation, handling and addressing routine Quality post-market surveillance compliance systems and processes related to Complaints handling systems, Field Actions and product hold orders, and provide inputs towards their effective resolution in collaboration with global counterparts.
- Track and trend complaints arising in Indian Sub-continent from various stakeholders (employees, distributors, customers, etc.) and coordinate with global counterparts
- Handle Vigilance issues (Field Corrective Action & Product Complaints)
- Conduct training to all new employees or refresher training on Product Complaint reporting, Field Corrective Action & Product Hold Orders
- Track and follow-up all quality training programs assigned to individuals across all departments.
- Promote Quality System across Distributors and leverage to Medtronic standards through visits, audits & follow-ups
- Plan, co-ordinate and implement various quality systems towards obtaining certifications and accreditations (ISO 13485, etc.) for India Medtronic activities (including warehouses, Technical Service Centre & other areas of the organization), as applicable.
- Prepare quality procedures and reports related to post-market surveillance required for management review. Effective control of documents by proper distribution and archival in database
- Handle and report Adverse Events from Clinical Trials to regulatory team and coordinate on this effectively
EHS
- Ensures effective and sustainable EHS systems, programs and processes are in place.
- Manages EHS job functions as assigned such as job safety analyses/risk assessments, EHS training, workplace incident analyses, EHS inspections, environmental regulatory reporting, data collection / analysis and internal audits.
- Comply with all applicable Environmental, Health and Safety laws, regulations (AERB & BARC) and Medtronic standards
- Co-ordinate with AERB and its affiliated labs to collect and distribute dosimeter badges and monitor the reports.
- Initiate recycling of wastes and conserving natural resources to emerge as a responsible corporate citizen in India
- Reduce Lost Time injuries for employees
Qualifications & Experience:
· Must have at least 4-6 years’ experience in the pharma/medical device/life science industry with at least 2-3 years' medical device experience in quality assurance.
· Experience in Quality systems implementation and maintenance; GMP/Quality Systems Regulations; ISO 13485
· Knowledge and competency in application of FDA, ISO 13485 and other regulatory requirements especially in the area of Quality Systems and Design Control as applied to projects from design inception to manufacturing release.
· Working knowledge of ISO 14001/18001 management system. Implementation of an ISO management system is a plus
Attributes:
· Easily communicate with colleagues, management and external authorities
· Be able to plan, manage, organize and report in an efficient way
· Be independent, persuasive, innovative and able to summarize
· Excellent verbal and written communication skills in English
Additional Information:
Experience: 4-6 years
Qualification: B.Pharm, M.Pharm, MBA, M.Tech, B.Tech
Location: Gurgaon / Delhi-NCR
Functional Area: QA
Industry Type: Pharma
Employment Type: Full Time
Job Type: Regular
End Date: 15th October, 2015
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