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The Position
Purpose:
Maintain the site’s Right to Operate and enable excellence in manufacturing by providing validation support to the production organization that results in safe, high quality, and continuously improving production.
Own, execute and improve the validation lifecycle from Plan to Retire, for manufacturing processes and equipment. This includes, but is not limited to oversight of Equipment, Facility, and Utility Qualification, Cleaning Validation, Shipping Validation in partnership with Distribution, and administration of the Periodic Review and Revalidation Program. Accountable for ensuring compliance with PQS and HA requirements.
Key Responsibilities:
Support the day-to-day operation of approved Validation SOPs / Plan / Policies for a multi-platform, multi-product, GMP biotech contract manufacturing facility.
·Develop Validation SOPs, templates, guidelines, Validation Protocols and Reports including supporting site discrepancies and deviations investigation / closure in line with corporate policies and standards.
· Provide guidance and direction on all validation activities at the Singapore site.
· Ensure that all validation activities with respect to process, cleaning, facilities/equipment and computerized system stated in validation plan/ protocol are carried out in accordance with relevant policies, standards, procedures and guidelines, and completed in a timely fashion.
· Participate actively in investigations or troubleshooting discrepancies/ deviation encountered during commissioning and qualification.
·Generate training materials and to conduct workshops on general validation activities.
· Serve as a technical subject matter expert (SME) in support of department functions.
· Participate in site Validation Maintenance Program.
· Prepare and review Turnover / Vendor Packages.
· Support Change Implementation on site.
· Support Validation / QA Audits as required, including Material Traceability Audits.
· Participate in external regulatory inspections as SME.
· Contribute, whenever possible, to raising the site awareness on the importance of validation at the Singapore site and within the industry.
· 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.
· 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.
· Any other tasks as and when assigned by Supervisor.
Qualifications:
· Degree in Life Sciences or Engineering discipline or equivalent
· 0-3 years of related working experience for degree holders or equivalent holders with combination of education and relative work experience
· Related working experience in a biotech or pharmaceutical operation environment is preferred
· Familiarity with Regulatory requirements and local Codes & Standards (e.g., FDA, EMEA, GAMP and ICHQ7).
· Good knowledge and experience of the practical and theoretical requirement of validation program in GMP facility
· Good oral and written communication skills
·Meticulous and Systematic
· Ability to adapt to rapidly changing priorities and the flexibility to support operations in accordance with the manufacturing schedule
· Must be highly motivated, able to work independently as well as a Team player, with strong focus on Safety, Quality and timeline.
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.
