Title: Sr.Executive/Asst.Manager-QA (Compliance)
Company Name: GME Group
Vacancy: Not specific
Job Location: Dhaka (Dhamrai)
Employment Status: Full-time
Educational Requirements:
∎ Master of Science (MSc) in Chemistry or Biochemistry
Experience Requirements:
∎ At least 5 year(s)
Job Responsibilities:
∎ Responsible for the QMS, Authority inspection, Audit & Compliance.
∎ Responsible for co-ordination and maintenance of Technical File and Site Master File, Quality Manual, Clinical Evaluation Report.
∎ Responsible for follow-up and acknowledgement of activities related to the Non-Conformity, Complaint, Change Control, Design Control (Quality Compliance Part), Corrective and Preventive Action, PMS, Customer Feedback.
∎ Responsible for Validation & Verification Coordination & Monitoring, Qualification & Calibration,Monitoring, Process Monitoring.
∎ Responsible for Document Preparation (Quality Compliance), Approval (ANC Part) of Quality Specification & Agreement.
∎ Responsible for Monitoring the activities related to the Distribution, Archiving & Withdrawal of QMS document.
∎ Attend public authority, certification body & Customer, Control & Maintenance of Internal & External Communication.
∎ Manage Registration activities as per regulatory affairs requirement.
∎ Risk Management of Product, Product Recall etc.
∎ Responsible for implementation of ISO 13485 & CE for the successful certification.
∎ Guide & train members of the Production, Engineering and QA team towards excellence work performance in line with regulatory requirements.
∎ Responsible for compliance and establish the Quality Management System as per ISO 13485.
Additional Requirements:
∎ Age 25 to 40 years
∎ Both males and females are allowed to apply
∎ Minimum 5 years in Medical Device manufacturing company/Pharmaceuticals company
Salary: Negotiable
Compensation & Other Benefits:
∎ T/A, Mobile bill, Tour allowance
∎ Festival Bonus: 2
∎ As per company policy.
Job Source: Bdjobs.com Online Job Posting.
Application Deadline: 15 Jun 2023
Company Information:
∎ 1 Jun 2023
∎ GME Group
∎ Address : Graphic Machinery & Equipment Ltd. (GME Group), GME House, Reflections Monem Villa, Plot # 21, Road # 13, Block # G, Niketan, Gulshan-1, Dhaka-1212, Bangladesh
∎ Web : www.gmegroup.net
∎ Business : GME Group the front-line sprinter in medical imaging consumables and medical equipments, graphic machineries, graphic films and equipments, inkjet & offset ink productions, agribusiness, real estate, camera, skin care and consumables sector. Sister concerns of GME Group and Principle affiliations with Fujifilm Corporation, Shimadzu Corporation, Screen, Sakurai, Boston Scientific, Medtronic, Bayer Health Care, Astalift, GME Agro, Reflection Holdings Limited, GME Life Style, Medi Graphic Trading Limited and Fuji Ink Industries Limited.
Category: Medical/Pharma
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Source: bdjobs.com