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[Expired] Senior / Quality Compliance Specialist

Roche Singapore Technical Operations Pte Ltd
Posted On :31 Aug 2017

 

Job Summary

  • Salary:   Undisclosed
  • Location: Singapore - West
  • Work Type: Permanent / Full Time
  • Min. Education Level: Degree
  • Field of Study: Not Applicable
  • Years of Experience: 7
  • Skills: Quality Management

Job Descriptions

Purpose
  • 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.

Key Responsibilities

Technical and Functional

Inspection Management (Health Authorities, self-inspection, internal audits):
  • Manage regulatory inspections, internal and external audits and paper-based inspections.
    • Support all required inspection preparation activities (e.g. providing necessary training to inspection support team and presenters, identification of risks, preparation of pre-request, management of logistics which include ART Room set up, SWAT team).
    • Assuming leadership role during an inspection.
    • Lead and manage post inspection response process and follow up with action owner/ team(s) to ensure inspection commitments are met per committed timelines, including communicating and coordination with global functions and/ or network sites and escalation of issues.
  • Independently lead and/ or execute site self-inspection program and inspection readiness activities at site to identify GMP compliance gaps/ risks.
    • Provide compliance expertise to the site, collaborate with stakeholders to identify and remediate compliance gaps.
    • Create internal audit schedule, develop audit plan/ agendas, identify audit scope and materials preparation, lead/ participate in self inspection, develop findings, write final audit report and follow up observation responses.
    • Support filings and submissions as requested by local PTR representatives.
    • Interface with Affiliates to maintain import licenses, support local Business Operations Functions to maintain and keep the necessary Wholesaler and Distribution Licenses if applicable.
Compliance program:
  • Participate in cross functional project teams, collaborate effectively with and influence key stakeholders to drive site compliance improvements.
  • Manage Quality Compliance Scorecard (QCS) program at site, including
    • Actively communicating new requirements and compliance trends to site stakeholders
    • Following up on compliance risk mitigation actions
  • Create, maintain and report inspection metric/ reports/ Key Performance Indicators to monitor site’s inspection readiness health status and as required by the site and global network.
Supplier Management:
  • Execute supplier management program at site, responsible for
    • Monitoring local suppliers performance and compliance with cGMP requirements and applicable regulations
    • Performing supplier audits of locally managed suppliers,
    • Serve as the primary point of contact at site and interface and collaborate with global SQM team
    • Support qualification of Site Services Providers with GMP impact.
Quality Agreements:
  • Management and maintenance of Quality Agreements, in collaboration with key stakeholders.
  • Developing others by coaching/mentoring less experienced employees and/ or interns.
Qualifications

Education:
  • Bachelor’s degree required (in a Science or technical field such as Pharmacy, Life science, Biology, Biochemistry, Chemistry or Engineering is preferred)
  • Graduate or higher level Degree is preferred
Experience:
  • 7 or more years’ quality, compliance or other relevant experience in the pharmaceutical, biopharmaceutical or related industry, or an equivalent combination of education and experiences.
Knowledge/Skills/Competencies:
  • Advance knowledge of Quality System principles, practices and standards for the pharmaceutical industry.
  • Strong analytical mind, with the ability to interpret and relate Quality standards for implementation and review.
  • Advance knowledge of cGMP relevant to the pharmaceutical industry; knowledge of the local and international GMP regulations and a strong familiarity with production operations.
  • Strong knowledge with audit or inspection management.
  • Demonstrated ability to communicate clearly and professionally both in writing and verbally.
  • Demonstrated ability to work independently and collaboratively on multidisciplinary and multifunctional teams. Have proven ability to work well under pressure.
  • Demonstrated ability to make sound decisions about scheduling, allocation of resources and management of priorities.
  • Takes responsibility, drives results and achieves expected outcomes.
  • Strong influencing ability and able to effectively build trust and relationships.
  • Detail oriented with strong leadership skills, problem solving ability and excellent interpersonal and communication skills; interacts with internal and external stakeholders and management.


About This Company

A Convergence of Intellect and Passion

Who we are

At Roche, 80 000 people across 150 countries are pushing 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, diversity and leveraging on each other's strengths. We work towards a common goal of helping patients live better lives - and are seeking people who have the same goals for themselves.  Roche Singapore Technical Operations (RSTO) currently operates a 1000-liter microbial manufacturing facility and an 80 000-liter cell culture manufacturing facility in Singapore. Our state-of-the-art facilities produce biologic medicines ranging from treatment for cancer and age-related ailments. 

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