Executive Quality Assurance (Contract Manufacturing)

Posted a month ago by Hemas Holdings PLC, Classification: Manufacturing

Morison Limited, a subsidiary of Hemas Holdings PLC, is a fully Sri Lankan owned company. We are one of Sri Lanka's largest pharmaceutical manufacturers, having led & guided the industry for more than eight decades with our pioneering spirit and drive. We are continuously committed towards enriching lives of consumers of Sri Lanka and beyond for generations to come. We are expanding our operations through a state of art manufacturing facility built to EUGMP specifications that will enable greater capacity and manufacturing flexibility in gearing up to compete globally.

Job Profile

  • Responsible in preparation of the contract manufacturing SOP and relevant protocols for each contract manufacturer.
  • Coordinate the vendor audits and record observations for improvement (Scriber).
  • Coordinate CAPA (?) derivation and prepare Auditee Response.
  • Prepare CAPA tracker and ensure timely implementation of the agreed CAPA.
  • Ensure actions mentioned in the quality agreement are compiled to by Morison Limited.
  • Act as a CFT member for the EU-GMP Certification.
  • Coordinate the quality audits/ focus group discussions with the EU consultants and monitor implementation of the agreed action plan / CAPA.
  • Responsible in Supplier Qualification process including, review the vendor declaration and the vendor surveillance, conduct vendor audits and obtain all relevant documents/certification for each supplier and ensure compliance to regulatory requirements and WHO/EU guidelines, conduct Risk assessment to each vendor and prepare the supplier quality agreement for each vendor.
  • Responsible in managing of Contract Service Providers.
  • Preparation / Submission of documents requested from QA by regulatory bodies.
  • Coordinate regulatory inspection by NMRA.

Applicant Profile

  • Candidate should possess a B.Sc. Degree in Science, Biotechnology, Biomedical Science or Pharmacy and Diploma in Quality Management System will be an added advantage
  • Minimum 2-3 years experience in a similar capacity related to Pharmaceutical/Manufacturing Industry.
  • Sound Knowledge on Pharmaceutical Manufacturing Process, Quality Management System, Auditing
  • Team player with a positive attitude with the willingness to learn

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