Job Responsibilities & Duties
- Perform Validation as per Medical Device Quality System as per ISO 13485, Clean room, 14971 and Sterilization as per ISO Standards.
- Prepare and control BPR, Label Sheets, batch production and document PDIR (Pre Dispatch Inspection Report).
- Manage COA documentation and Audits.
- Supervise Packaging as per Customer requirement including maintaining inventory & stock of all packing material for the CleanRoom such as Labels, marking material, poly bags, pouches, cleaning material etc.
- Ensure routine maintenance/ AMC of all the equipment/ machinery in CleanRoom.
- Candidates with global exposure of New Product Innovations with–USA, Europe, Middle east, APAC markets will be preferred.
- Manage cleanroom operations involving resource planning, material planning, in-process inspection, and team building.
- co-ordination with internal departments & external customers Effective
- communicator with excellent relationship manage.
Desired Candidate ProfileDesired Education, Experience, Skills & Competencies:
- Bachelors/Master’s degree in Mechanical Engineering/ Bio-Sciences.
- 5+ year Cleanroom work experience from Medical Devices Industry.
- Adept in managing operations involving resource planning, materials planning, in-process inspection, team building, and co-ordination with internal & external customers Effectively.
- Must be familiar with ISO 13485 and ISO 14971Internal Audit Requirements.
- Superb ability to effectively communicate with staff members across the organization.
- Excellent computer and internet search skills.
- Strong ability to multi-task and to meet business deadlines.
- Experience in Packaging project transfer.
- Experience in Cleaning validation and Biocompatibility studies.
Role:Quality Assurance/Quality Control Executive
Salary: 3,00,000 - 4,50,000 P.A.
Industry:Medical Devices / Equipments
Employment Type:Full Time, Permanent
UG:B.Sc in Any Specialization,B.Tech/B.E. in Any Specialization,B.Pharma in Pharmacy
PG:Post Graduation Not Required
Doctorate:Doctorate Not Required
Bee5 Manpower Consulting