Quality Control Specialist (Pharma / MNC | Full-Time, Office Hours) #HJG

Key Responsibilities

• Investigate and resolve laboratory incidents, ensuring proper documentation and corrective actions.

• Review and approve laboratory investigation reports, including out-of-specification (OOS) reports.

• Evaluate the adequacy of corrective and preventative actions and assess their impact on materials.

• Review and approve analytical procedures for compliance with company policies, ICH guidelines, and regional regulatory requirements.

• Assist in the preparation of quality agreements and perform periodic supplier evaluations to ensure regulatory and company compliance.

• Conduct incoming quality control inspections of raw materials to verify conformance with specifications.

• Coordinate sampling of raw materials with production planners and testing laboratories, ensuring timely testing and retesting.

• Track the status of raw materials from receipt to final disposition, including SAP management of retest and expiration dates.

• Sample and monitor the purified water system used in laboratory operations; review trend reports and identify potential root causes of out-of-specification or out-of-trend results.

• Manage clinical supply operations logbook system and perform quality reviews to ensure adherence to company procedures and cGMP standards.
  
  

  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.
  • Interpreting and evaluating data and summarizing results.
  • Good interpersonal skills with team player orientation,
  • Min Degree in Science or equivalent with at least 2  years of relevant experience in the pharmaceutical / chemical industry.
  • Experience in operating laboratory equipment such as HPLC, GC , KF Titrators. 
  • Working knowledge of cGMP and regulatory requirements related to Quality is an advantage
  • 5 days office hours

   

  If you are interested in the position, do kindly drop your most updated resume to

  joshua.gan@recruitexpress.com.sg & leonleong@recruitexpress.com.sg

   (Attn: Senior QC Analyst)

   

  Thank You.

   

  Leon Leong De Cong
  R1551708

  Recruit Express Pte Ltd (Healthcare & Lifesciences Division)
  EA License: 99C4599