QA Specialist Trainee
2 days ago
Overview
QA Specialist Trainee - Train & Place Program at Roche. Join to apply for this role at Roche.
The Position
Purpose
Provide Quality oversight of Qualification, Validation and Computer System Validation activities. Support QVCSV to ensure an effective site qualification and validation program is maintained, including periodic reviews, requalification and revalidation. Support 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 requirements. Collaborate closely with the team to maintain the inventory of computerized systems and ensure that procedures for Validation, Qualification, and Facility & Equipment (F&E) Support Processes align with current Health Authority requirements.
Responsibilities
Safety, Health & Environment: Comply with all site Safety, Health & Environmental requirements, never put oneself or others at safety or health risks, and report any workplace accidents, near misses and hazards as soon as practicable.
Observe site security measures and report any suspicious activity or damaged security mechanisms to Site Security.
Lean Production System: Embody the Lean Production System with a continuous improvement mindset and apply LPS tools for 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 support. Review and approve qualification and validation lifecycle documents. Perform periodic reviews of equipment & systems as a Quality reviewer. Participate in Local Change Management, self-inspections, regulatory inspections and partner audits. Assist in implementing Quality Requirements and Global Standards & Procedures. Keep the team 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: No work experience in the pharmaceutical or related industry required (may vary by site).
Knowledge/Skills/Competencies: Basic understanding of Quality System principles, cGMP, Pharmaceutical Quality Systems and Processes, and validation of procedures for QA of starting materials and excipients. Strong teamwork, fast learning, problem-solving, attention to detail, and English communication skills.
Seniority level
Entry level
Employment type
Full-time
Job function
Training and Education
Industries
Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing
Who we are
A healthier future drives us to innovate. Our global team of more than 100,000 employees advances science to ensure healthcare access for generations. We pursue life-changing solutions and empower each other to build a healthier future.
Roche is an Equal Opportunity Employer.
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