Packaging, Sterilization and Cleanroom Executive and Engineer

from 5 to 8 year(s) of Experience
3,00,000 - 4,50,000 P.A.

Job Description

Roles and Responsibilities

Designation: Packaging, Sterilization andCleanroom Executive/ Engineer

Reports to: QA Manager

Industry: Medical Devices/ Automobile Industry

Place of Posting: Sonepat 2 KM from Delhi Border

Pick & Drop available from Jahangir Puri & Pitampura metro


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.
Key Skills:

BPR, COA, GHTF, Packaging, Validation, Clean Room, Cleanroom, Sterilization, Quality Assurance, QC, Quality Control, QA, 13485, 14971, RCA, CAPA, Audits, Labelling, Marking, Product Traceability



Desired Candidate Profile

Desired 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.
Key Skills:

BPR, COA, GHTF, Packaging, Validation, Clean Room, Cleanroom, Sterilization, Quality Assurance, QC, Quality Control, QA, 13485, 14971, RCA, CAPA, Audits, Labelling, Marking, Product Traceability




Role:Quality Assurance/Quality Control Executive

Salary: 3,00,000 - 4,50,000 P.A.

Industry:Medical Devices / Equipments

Functional Area:Production, Manufacturing, Maintenance

Role Category:Production/Manufacturing/Maintenance

Employment Type:Full Time, Permanent

Education-

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

Company Profile

Bee5 Manpower Consulting

The company is a global leader in Medical Devises with deep domain expertise in all aspects of Medical Devises in Orthopedics range. Within ten years of its inception, with distinguishable quality and value advantage delivered by its generic orthopedic implants has earned it the credibility to afford a rapidly expanding customer base, opportunities to provide OEM services to leading names in the industry as well as the confidence of the medical community at large. By establishing strong foundation of proven customer satisfaction, the company is focused on building a world of exciting possibilities in Research and Development, innovation, customization and education.
Company Info
View Contact Details+

Contact Company:Bee5 Manpower Consulting

Reference Id:Packaging, Sterilization and Cleanroom Executive and Engineer

Website:http://www.bee5manpowerconsulting.com