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 Overview:
- Able to demonstrate the understanding on ISO 13485
- Understanding on 21 CFR 803 , Complaints process and critical timelines.
- Must be able to properly use and navigate tools and MS Office.
- Able to communicate professionally and concisely to all business partners and other Wipro employees.
- Able to think critically to determine the type of questions which need to be asked to gather necessary information
- Able to properly groom their direct reports to sustain and drive performance and discipline.
- Good problem solving and analytical skills
- Good customer service skills
Qualifications:
Bachelors of
Science/Engineering/Pharmacy OR Life
science graduates
Like Microbiology,
Gen Engg, Biology,
Bio Chem, MSc etc)
Science/Engineering/Pharmacy OR Life
science graduates
Like Microbiology,
Gen Engg, Biology,
Bio Chem, MSc etc)
Roles & Responsibilities:
Shall meet same requirements in addition to the
following:
following:
- Communicates objectives and expectations to the team.
- Conducts Performance Reviews for Team Leaders
- Leads the Status/Operations calls with the clients
- Overall responsibility for achieving Client’s service level expectations and maintaining high quality delivery for Medical Device Post market surveillance project
- Support in managing efficient work allocation and tracks the overall performance of team members
- Manages the PMS function through registration, through potential regulatory reporting, sample retrieval, investigation, customer response and ultimately to closure/reopening as needed
- Evaluates, encodes, and maintains Quality Records based from the Product Issues processed by the complaint Specialists.
- Performs reviews and assessments of complaints processed by peers as part of cross utilization approach
- Responsible for contacting SME’s, Lead and Client as needed for escalation and to obtain complaint closure
- Remediates any disconnects and misunderstanding with the process through calibrations, coaching, and facilitated client communications.
- Work with multiple functions to meet customer needs with a focus on business process improvement and customer relations.
- Responsible for completion of the team’s schedule adherence.
- Excellent verbal and written communications in English
- Ability to plan, prioritize, organize and communicate with client & Team leads
- Perform all other duties assigned by supervisor or manager from time to time
- Leadership skills – Coaching; time management; analytical; motivational skills; Conflict resolution skills
