Compliance Specialist - TnP

Job description

The Position

• Responsible for management of all compliance programs and providing Quality oversight of compliance activities in accordance with Roche policies, standards, procedures and Global cGMPs.

• Management and/or participation of inspection related activities such as:

  • Regulatory inspections and corporate GMP audits,

  • Internal inspection program,

  • Inspection readiness activities,

  • Supplier management program and

  • Emerging regulations and systematic evaluation of new requirements

• Management and maintenance of Quality Agreements.

• Creation and oversight of Quality Compliance Performance metrics.

• Serve as Regulatory liaison by supporting queries from Health Authorities' and internal business partners.

• Participate in cross-functional project teams and work effectively with multiple disciplines and personalities to support licensure of Singapore Manufacturing Facility

The Career Conversion Programme (CCP) (Train-and-Place) for Advanced Biopharmaceuticals Manufacturing Executives/Professionals is a talent development programme aimed at building the next generation of skilled manpower for Singapore’s Biopharmaceuticals manufacturing industry in anticipation of hiring demand. This programme is jointly supported by the Workforce Singapore (WSG) and Workforce Advancement Federation (WAF). The training programme consists of 15 months of local attachment with Roche.

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.