QA MANAGER

Kotra Pharma (M) Sdn Bhd - No. 1, 2 & 3, Jalan TTC 12, Cheng Industrial Estate, 75250 Melaka.
Job Description
  • Reports to the General Manager (Plant) on all matters related to the Quality Management System. This include Documentation, Training, Validation and Compliance.
  • Responsible for the implementation of an effective Quality Management System in accordance to cGMP based on PIC/S, ISO standard and current technological requirements in pharmaceutical manufacturing and quality control.
  • Responsible for effective management of the Validation Master Plan for existing and new equipment and processes.
  • Plan, coordinate and successfully execute validation and re-validation activities for area of responsibility.
  • To participate in project review meetings for the development of new product formulations and production lines to ensure they are designed and developed to comply with the requirements of Good Manufacturing Practices and Good Laboratory Practices and are conducted in accordance to approved procedures.
  • Responsible for the Internal Quality Audit Program, Vendor Audit Program and third party audits in the event of contract manufacture of any Company’s product.
Job Specifications
  • Minimum Bachelor's Degree or Professional Degree in Pharmacy, Biology, Chemical Engineering, Biotechnology or Science related subjects.
  • At least 7-8 years of hands-on experience in validation activities or related working experience in pharmaceutical or related industry.
  • Experienced in ISO, GMP, HACCP, validation and calibration procedures.
  • Exposure in sterile manufacturing will be an advantage.
  • Strong analyzing skills in making strategic and sound decision on quality matter.
  • Strong characteristics in demonstrating excellent organizational and planning skills in implementing systems or projects.
  • Excellent interpersonal and communication skills (interface with international auditing authorities) with good command of written and spoken English.
Please ensure your CV or profile demonstrates how you meet the desired skills and experience.
 
We thank all candidates for their expressed interest. However, only those who are shortlisted for an interview will be notified.


Open 21 Desember 2017
Closed pada 20 Januari 2018

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Profil Syarikat

Kotra Pharma (M) Sdn Bhd

Kotra Pharma (M) Sdn Bhd

Malaysia - Melaka - Cheng

With over 30 years of pharmaceutical experience under its belt, Kotra Pharma is well on its way to achieve its mission to be the centre of excellence for the pharmaceutical industry. Having grown from a Malaysian brand to globally recognised in over 30 countries, Kotra Pharma rapid progress did not go unnoticed.
Kotra Pharma received one of the highest forms of acknowledgement from the National Pharmaceutical Control Bureau, Ministry of Health Malaysia, whereby the company was nominated and awarded the inaugural Industry Excellence Award 2012, for its leadership in the field of Good Manufacturing Practice (GMP).
Along with this recognition, Kotra Pharma was bestowed from the National Pharmaceutical Company Of The Year for 2011 & 2014 by Frost & Sullivan, a US-based consulting firm, for its leadership in customer value and innovation.
These accolades serve to further establish Kotra Pharma's presence within the pharmaceutical industry as well as encourage us as a company to continuously grow and seek better product innovation, manufacturing excellence and geographical expansion to bring accessible healthcare to all.
This effort, true to our vision of Humanising Health where we believe everyone deserve a healthier tomorrow, is further supported by Kotra Pharma's commitment to deliver quality medicines to healthcare providers worldwide by applying cutting edge pharmaceutical research and manufacturing technology.
 
Product & Services
At Kotra Pharma, we believe that everyone deserves a healthier tomorrow. Its every individual's right to live a healthy life to the fullest, and thus, we are committed to bring top-notch health products to the world. By humanising healthcare, we see beyond instrument and medicine for the general well-being of everyone.
To date, our pharmaceutical (Axcel® and Vaxcel®) and nutraceutical products (Appeton®), have globally benefited patient and communities as we continue to grow, seeking new and improved ways to constantly fulfill our healthcare needs in an ever changing environment.
Committed to our vision, we have invested USD 50 million in the first phase of total USD 150 million state-of-the-art manufacturing and research facilities, which constitute the largest single-investment in the Malaysia pharmaceutical industry to date.
 

Mengapa bergabung dengan kami?

 
As a member of the Kotra Pharma team, you will be given the opportunity to find creative solutions to today critical healthcare issues and be inspired to enable others to live to the fullest.
 
Whether your skills and passion lie in research, manufacturing or sales, we invite you to explore and apply for the opportunities available at Kotra Pharma. If you want to make a difference in this industry, begin with us.