- Experience
- Any
- Salary
- —
- Openings
- 1
- Posted
- 3 days ago
- Work mode
- In office
- Education
- Diploma/Degree in Engineering or Science
- Resume
- Required to apply
Where you'll work
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Job description
About Roche and Role Overview
At Roche, you are encouraged to be your authentic self, valued and respected for your unique qualities. This supportive culture fosters open communication and genuine relationships, allowing professional and personal growth. Roche is committed to advancing healthcare through innovation and access for all people globally. We invite you to join our team where every perspective matters.
Responsibilities
- Maintain and consistently enhance the Change Control systems and related procedures to support compliance.
- Ensure strict adherence to Good Manufacturing Practice (GMP) within all change control activities.
- Develop proficiency in Quality Assurance Change Control processes and associated tools, and assist with training change users as necessary.
- Assess Change Control requests in terms of process impact, validation, regulatory compliance, and product implications.
- Oversee the review and approval workflows to facilitate timely implementation of changes.
- Manage major site changes to satisfy global change control board expectations and adhere to project timelines.
- Engage in cross-functional and cross-site change management discussions and initiatives.
- Collaborate with relevant departments to ensure smooth and effective execution of change control processes and provide support to stakeholders.
- Complete required Change Control actions before lifting any lot disposition restrictions.
- Contribute to the creation and delivery of training materials and qualifications for Change Control processes and management software.
- Review Change Records to support the Annual Product Review.
- Champion continual improvement in Change Control procedures.
- Support audits and regulatory inspections, including reviewing documentation related to facilities, utilities, and equipment.
Safety and Lean Production
- Adhere to all site Safety, Health & Environmental (SHE) policies to maintain a safe workplace, promptly reporting accidents, near misses, or hazards.
- Follow site security protocols fully, reporting any suspicious activity or security defects immediately.
- Embrace Lean Production System (LPS) principles, employing its tools to foster a mindset of ongoing improvement.
Collaboration Interfaces
- Work closely with Manufacturing, Local MSAT, Engineering, QA Operations, Quality Control, Global Change Management BPOs and BPMs, and Regulatory teams.
Qualifications
- Diploma or Degree in Engineering or Science is preferred.
- Open to fresh graduates and mid-career professionals transitioning from other industries.
- Strong understanding of Change Control principles and pharmaceutical industry standards.
- In-depth knowledge of current Good Manufacturing Practices (cGMP) applicable to pharmaceuticals.
- Detail-oriented, systematic, and analytical in evaluating and completing tasks.
- Excellent verbal and written communication skills in English.
About Roche
Roche is driven by a commitment to foster a healthier future through innovation. With over 100,000 employees worldwide, we advance science and provide accessible healthcare solutions. Our medicines impact over 26 million lives, and our diagnostics are integral to over 30 billion tests. We cultivate creativity, ambition, and mutual empowerment to deliver transformative healthcare globally.
Roche is proud to be an Equal Opportunity Employer.
Minimum education
Diploma / ITI / Vocational