At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

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, ManufacturingQuality 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 ProcessesBasic 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 skillsExceptional attention to detail with a methodical and organized approach to tasks.Demonstrate excellent verbal and written communication skills in English

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.