QA Specialist Trainee

2 days ago

Tuas Bay, Singapore Roche Services & Solutions Operations APAC Full time $40,000 - $80,000 per year

Purpose

  • Provide Quality oversight of Qualification, Validation and Computer System Validation activities.
  • Supports QVCSV to ensure an effective site qualification and validation program is maintained, including periodic reviews, requalification and revalidation.
  • Supports in ensuring an effective Validation Program, periodic validation review and revalidation program is developed, implemented, and maintained
  • Responsible for ensuring operational and laboratory areas and computerized systems (including processes and utilities) are qualified and validated according to current GMPs.
  • Collaborate closely with the team to ensure that all qualified and validated systems, processes, and computerized systems are consistently maintained, with procedures aligned to current Health Authority (HA) requirements.
  • Collaborate closely with the team to maintain the inventory of computerized systems and ensure that procedures for Validation, Qualification, and F&E Support Processes align with current Health Authority (HA) requirements.

Key Responsibilities

  • Safety, Health & Environment:

  • Comply with all RSTO's Safety, Health & Environmental (SHE) requirements, never put oneself and others at safety & health risks, and report any workplace accidents, near misses and hazards as soon as practicable.

  • Observe all RSTO's site security measures at all times and report any suspicious characters/objects & damaged security mechanisms to Site Security immediately.

  • Lean Production System:

  • Embody the PT Lean Production System (LPS), while demonstrating a continuous improvement mindset and behaviors through the use and application of LPS tools for continuous improvement initiatives.

  • Technical and Functional:

  • Ensure GMP requirements are met for qualification and validation of manufacturing and laboratory equipment/systems, buildings, utilities, computer systems and IT system support, etc.

  • Review and approve qualification and validation lifecycle documents.
  • Perform periodic reviews of equipment & systems as a Quality reviewer. Execute periodic review & qualification studies as required, as assigned by supervisor.
  • Participating in the Local Change Management process as required
  • Participating in self-inspections, supporting regulatory inspections and partner audits
  • Assist in the implementation of Quality Requirements and Global Standards & Procedures.
  • Ensure the team and team head are regularly updated on significant qualification and validation issues.

Key Interfaces:

  • Local MSAT, Facilities & Engineering, Manufacturing
  • Quality Functions (e.g. QA Operations, QC, Compliance)
  • Site ITOT

Qualifications

  • Education:

  • Bachelor's degree in science, engineering or other relevant disciplines.

  • Experience (may vary depending on site size/scope):

  • No work experience in the pharmaceutical or related industry required

  • Knowledge/Skills/Competencies

  • Basic understanding of Quality System principles, practices and standards for the pharmaceutical industry

  • Basic understanding of cGMP relevant to the pharmaceutical industry
  • Basic understanding of Pharmaceutical Quality Systems and Processes
  • Basic understanding of the implementation, qualification and validation of procedures for quality control of active ingredients and excipients
  • Team player, fast learner, problem solver, possesses a continuous learning attitude, systematic thinking, planning and self-organizing skills
  • Exceptional attention to detail with a methodical and organized approach to tasks.
  • Demonstrate excellent verbal and written communication skills in English

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