Dear Job Seekers,
MME Introduce, excellent job opportunity for your bright career. Find below the details and revert back if you are from same industry and taking care of similar job responsibility. Only Serious job seekers need to share their application.
Designation: MDR Associate
Industry: Manufacturing/Pharmaceutical
Qualification: BS degree
Experience:- 1-3 years Quality/Compliance Experience in Medical Device
Min 1 year of MDD to MDR transitioning project experience
Location: Bangalore
Working days: 5 Days
Working Timings: USA – Male 2 to 11pm & Female – 7am – 4pm
Job description
- Possesses knowledge related to FDA, Health Canada and pharmacy regulatory requirements
- Has worked in an environment that has regulatory or accreditation requirements
- Ensure production and testing records/results are complete, accurate, and documented according to procedures, GDP and cGMP requirements.
- Ensure facilities, equipment, materials, organization, processes and procedures comply with cGMP practices and other applicable regulations.
- Drive closure/completion (including review and approve) of cGMP processes, procedures, documents and records, including but not limited to deviations, investigations, corrective action/preventative actions (CAPA), change control records and validations.
- Audit and inspection support.
Duties:
- Provide expert content to transition 15 plus technical files to MDR compliant Technical Documents for submission to the to European representatives and NB.
- Take care of the meeting minutes (e.g. deliverable status and action items and follow-up on action items)
- Contribute to the issue resolution
- Follow up on document reviews/ approvals.
- Provide, maintain and communicate pertinent documents on the companies database or SharePoint
- ensure/communicate technical feasibility
- Ensure resource availability and allocation
- Provide regular update on and track project(s) progress
- Use appropriate verification techniques to navigate changes in project scope and timelines
- Perform risk management to minimize project risks
- Establish and maintain relationships with internal and external stakeholders
- Create and maintain project documentation
- Excellent written and verbal communication skills
- Excellent planning skills and ability to learn quickly, multi-task, and handle multiple priorities
- Excellent interpersonal, analytical, problem-solving, process thinking skills
NOTE: We are not having any registration charges Or service fee from job seekers but don’t entertain unwanted job seekers who are not serious for their job change. Expecting genuine application to avoid fraud & Fake candidates.
If Interested please revert back with your updated cv and photograph at [email protected] or for more details you can contact us at 9871008190.
Best Regards
Ms. Anamika
MM Enterprises