Quality Assurance Specialist

22 hours ago

Singapore RECRUIT EXPRESS PTE LTD Full time
Job Description

We are seeking a highly skilled Quality Assurance Specialist to join our team in the pharmaceutical industry. In this role, you will be responsible for ensuring the quality and compliance of our products and processes.

Main Responsibilities
  • Investigate and resolve laboratory incidents, ensuring that all issues are addressed promptly and effectively.
  • Perform quality assurance reviews and approvals of laboratory investigation reports, including out-of-specification reports, to ensure compliance with company policies and regulatory requirements.
  • Determine if corrective and preventative actions are adequate and evaluate the impact on materials, ensuring that all necessary steps are taken to prevent recurrence.
  • Review and approve analytical procedures for compliance with company policies, ICH and regional requirements, to ensure that all testing is performed accurately and efficiently.
  • Assist in the preparation of quality agreements and perform periodic supplier evaluations to ensure compliance with regulatory requirements and company policies.
  • Perform incoming quality control inspections of raw materials to ensure compliance with specifications and departmental procedures, identifying any non-conformities or potential issues.
  • Sampling of raw materials and coordinating with production planners and testing laboratories to ensure that raw materials are tested and retested at the required intervals, tracking the status of raw materials from receipt to disposition.
  • Manage the status and disposition of raw materials in SAP, including the retest/expiration dates of released raw materials, ensuring accurate and timely reporting.
  • Perform sampling of the purified water system used in laboratory operations, reviewing water system trend reports and assisting in identifying potential root causes of out-of-specification and out-of-trend results.
  • Manage the clinical supply operations logbook system and perform quality reviews of records to ensure compliance with company procedures and cGMPs, maintaining accurate and up-to-date records.
Requirements
  • Good knowledge of cGMP pharmaceutical manufacturing and inspection requirements of pharmaceutical products, interpreting multiple standards and applying them to department activities.
  • Detail-oriented with proven organizational skills, handling a wide variety of tasks under time constraints, and prioritizing tasks effectively.
  • Interpreting and evaluating data and summarizing results, communicating findings effectively to stakeholders.
  • Good interpersonal skills with a team player orientation, working collaboratively with cross-functional teams to achieve common goals.
  • Min Degree in Science or equivalent with at least 2 years of relevant experience in the pharmaceutical/chemical industry, with experience in operating laboratory equipment such as HPLC, GC, and KF Titrators.
  • Working knowledge of cGMP and regulatory requirements related to Quality, an advantage in this role.
  • 5 days office hours, with a competitive salary ranging between SGD $50,000 - $70,000 per annum, depending on experience.

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