Adept Manpower Solutions Pte Ltd-1
Adept Manpower is a Singapore based Employment Agency that is a one-stop solutions to all your manpower needs. We are your trusted partners that specialise in Executive Search, Permanent Placement, Temp & Contract Placement and Foreign Recruitment.
We identify, nurture and deliver best-fit candidates that are crucial to a company's growth and business performance. We take pride in our dedication and commitment to match the right people to the right positions and vice versa, standing ready to support in any aspect.
We aim to foster long term business relationships and not one-off engagement. We seek to understand about your business establishment and the people you employ, to be able to identify an appropriate candidates to fit the culture and the job scope of your organization.
Unlike many of our competitors, our consultants specialise within industry sectors, ensuring you to receive knowledgeable service for the specific roles for which you are recruiting.
QA Manager (Medical Devices)
jobsDB Ref. JSG400003003030404
- Patient Safety – SISPQ of products
- Liaise with Medical Devices customers to identify and meet need
- Develop new business with country teams and support new business proposals as needed
- Implementing Quality Policy, Manuals, Directives and Guidelines for the Healthcare Sector
- CSV – GAMP 5 experiences – ensuring all systems and equipment follow GAMP and meet legal requirements.
- Maintain standards in order to retain licenses to allow sites to operate / licenses retained
- To provide Quality Healthcare Management support to Medical devices sites and act as the responsible person
- Managing drug licenses wholesale/Supply/Manufacturing
- Maintaining QTA (Quality Technical Agreements)
- Managing the reporting of Deviations, CAPAs and Change Control
- Manage CSV Computer Systems Validation projects
- QRM ICH Q9 & ISO 13485 , GMPs, GxP Training
- Managing Validation Master Plans and Site Master Files in accordance with WHO
- Maintain links with appropriate professional bodies and licensing authorities
- Ensure our pharmaceutical facilities are validated in accordance with regulations
- Undertake various types of audits
- Support the Regional QA and QRA Leads
- Minimum of 3 years Quality experience within Medical Devices industry having a thorough knowledge of ISO13485, GDPMDS, cGMP/GDP.
- Experience of implementing Quality Management Systems ie ICH Q10, ISO 9001 and or ISO 13485
- Experience of dealing with regulatory bodies e.g. HSA, FDA
- Experience hosting customer audits and HSA regulatory inspections
- Experienced qualified or registered auditor with Notified body or IRCA equivalent
- Experience of complying to Medical Device Regulations including In Vitro Diagnostics, and Active Implantable Devices
- Experience of Computer Systems Validation – member of ISPE
- Previous experience of Warehouse Solution Management and the implications on how these impact of Good Distribution Practice
- Understanding of the legal obligations of logistics in the Healthcare environment eg dangerous goods, importing from outside a national country
Interested candidate please
Forward your resume to (R1111325) linda @adeptmanpower.com or call +(65) 68951810 for further discussion.
To Apply :
Please remember to input the following information in your resume: -
1) Current salary
2) Expected salary
3) Reasons for leaving (Past and present employment)
4) Notice period
5) Position applied for in the email
Due to the high volume of applications, we regret to inform only successful shortlisted candidates will be notified.
To find out more, please check on our Employment Agency website at www.adeptmanpower.com.
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