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The Position

General         

Department: Quality

Reports to: Head of MQA & QATS

Purpose

Provide QA oversight for RSTO to ensure that investigational medicinal products (IMPs) and commercial medicinal products are manufactured in accordance with global Roche, Pharmaceutical Quality System (PQS) and local site requirements.Responsible for escalation of quality issues following the criteria defined in current governing documentsSupport and/or perform routine “Make, Assess, Release” operations to meet targets and timelinesParticipate in the design and implementation of department and cross-functional initiativesTo undertake additional responsibilities as required by Quality Management to meet business needs.

Key Responsibilities

Technical and Functional:

Perform batch record, batch reports, logbook, cGMP documents and audit trail review to ensure quality of product, compliance to Roche requirements and on-time batch disposition per defined adherence to lead timePerform the following activities with QA oversight in accordance with Health Authority, Roche site and global PQS requirements:

-     Provide guidance on categorization of unplanned events

GMP area, Utilities and equipment releaseReview and approve discrepancies justification for resuming GMP processing.Execute Periodic Floor WalkPerform assigned tasks and manage competing priorities while meeting timelines to achieve company goals and department objectivesNotify Senior Management of potential quality, regulatory and compliance issues

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 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.

Qualifications

Degree in Life Sciences or Engineering discipline or equivalent 1-3 years of related working experience for degree holders or equivalent holders with combination of education and relative work experienceRelated working experience in a biotech or pharmaceutical operating environment is a plusGood knowledge of cGMP and GDP relevant to the pharmaceutical industryExecutes defined procedures well and shows progression in performing tasks independentlyDisplays good level of problem solving ability and begins to offer suggestions on complex issuesAbility to prioritise, plan and manage deliverables effectivelyMeticulous, systematic and of an analytical mindGood interpersonal, oral and written communication skillsProactive team playerFlexible in work hours (including shift work) to meet business objectives

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an Equal Opportunity Employer.