Job Description

The Position Key Responsibilities

• Facilitate and identify technical, procedural and equipment issues from discrepant events.
• Collaborate with cross-functional groups identify, design and implement process and system improvements and initiatives.
• Ownership to implement corrective and preventative actions in timely manner.
• Data management, trending and analysis to identifying systemic issues.
• Drive continuous improvement to develop and implement programs in cross-functional collaboration to reduce defects in identified problem areas.
• Ensure safe manufacturing work environment that complies with SHE requirements.

Job Responsibilities

• Manage the discrepancy end-to-end process as Discrepancy Owner in accordance with procedures, performance measures, and standard lead times.
• Manage the remediation as Change Owner working collaboratively across several functions to achieve timely closure.
• Manage the causal analysis as RCA Facilitator in cross-functional discussions associated with discrepancy cause and impact analysis.
• Manage assignments that are complex in nature where independent action and a high degree of initiative are required in resolving problems and developing recommendations.
• Support and participate in site inspection readiness initiatives, audits, & regulatory inspections.
• Manage work and competing priorities to achieve department objectives and company goals.
• Provide input to the development to personal performance goals and departmental objectives
• Collaborate with Management to establish and meet targets and timelines
• Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance

Safety, Health & Environment:

• Comply with all RSTO\xe2\x80\x99s 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\xe2\x80\x99s 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 (education/experience/knowledge/skills/competencies)

• At least a degree in a relevant science/engineering discipline.
• At least 5-7 years of relevant experience in the pharmaceutical industry.
• Good knowledge of international cGMP and compliance requirements
• Proficiency of the technical process and workflow of TrackWise
• Display good level of problem solving ability and provide suggestion/alternative solutions on complex issues resolution.
• Good interpersonal, oral and written communication skills
• Experience with mammalian/bacterial biopharmaceutical production strongly preferred.

Who we are At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we\xe2\x80\x99ve become one of the world\xe2\x80\x99s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity. Roche is an Equal Opportunity Employer.