quality assurance/regulatory affairs in Kuala Lumpur

posted
contact
nigel kheu, randstad
job type
permanent
salary
RM 10,000 - RM 15,000 per year

job details

posted
location
kuala lumpur, wilayah persekutuan
specialism
manufacturing
job type
permanent
working hours
Full-Time
salary
RM 10,000 - RM 15,000 per year
reference number
91M0151090_1606905043
contact
nigel kheu, randstad
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job description

about the company
We are looking for a QA/RA Manager for one of the public listed company that is looking to grow their market share in Malaysia. This position requires your urgent care

  • Reporting to Plant Manager


about the job
The candidate will be resposible to ensure that the products that were manufactured are in compliance within the acceptable DPM levels and AQL standards settig by the international regulatory agencies. Besides that, the manager also needs to ensure that the products meets the compliance of FDA, CE, EN certification ISO 13485, ISO 9001 etc. The manager is to also lead the licesing, legal compliance and license renewal for the safety and efficacy of the products, wich includes product listing and registration.

The QA/RA SOP is to be set up for the downline staff which includes making improvement to the QA processes, also implementing cost saving processes which is streamline to the QA/RA function. The QA/RA manager would need to liase with the regulatory authorities and agents. Onging support for re3gulatory issues and questionaire will need to be provided along with teh regulatory support for the marketed products. Keeping up with the changes in regulatory legislation and guideline s necessary along with updating as well.

about the manager/team

  • Bachelor Degree in Chemistry or relevant background
  • Minimum 5 years working experience in Glove Manufacturing industry. Experience in set-up from scratch will be desirable
  • Preferably Snr Manager with exposure in US & Europe markets
  • Excellent command of spoken and written English, Bahasa with Mandarin optional
  • Applicant must be willing to work in Kapar, Selangor



skills

no additional skills required

qualification

no additional qualifications required

educational requirements

Bachelor Degree