QA Specialist Trainee - Train & Place Program

• 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.

• 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.

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

• 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

Roche