Shire QO Specialist II in Woodlands Industrial Park (Baxalta), Singapore

Primary Objectives of this Job

This position is a member of the Quality Operations (QO) team which is Quality representative and partner for the manufacturing and facility engineering team to ensure GMP compliance at Shire Singapore.

Responsibilities

  1. Quality Systems Representative
  • Member of the QO team in ensuring Quality oversight at the manufacturing suite and/or Facility Engineering.

  • Partner the manufacturing and/or facility engineering team and helping with implementation and adherence to the various Quality systems and GMP requirements at the manufacturing suite

  • Lead/organise sessions/meetings for the manufacturing and/or facility engineering team for information learning & sharing and alignment of best practices

  • Support the compliance, regulatory, audits and training activities as required and any other responsibilities as assigned by Supervisor

  1. Routine QO Operations
  • Revise & Participate in the development and writing of procedures pertaining to the QO operations.

  • Together with the SME, assist the manufacturing and/or facility engineering team with development and writing of process SOPs and Master Batch Records and ensure that it complies with current good practices and the applicable DMs/DPs and regulatory requirements.

  • Own events relating to Quality Operations. Participating in investigations relating to manufacturing/facilities/utilities and assist in the writing and review/ approval of the investigation report relating to manufacturing/facility engineering/environmental monitoring.

  • Review of the manufacturing batch records and revision of MBR/MFR/SOP.

  • Participate as SME the gap analysis for current SOP/practices with the various subject matter expert to ensure compliance with DMs/DPs revision, where gaps are identified, ensure that an implementation/mitigation plan is in place and follow-through to completion.

  • Participate in cross-function investigations

  • Support the manufacturing and/or facility engineering team with any quality interpretation, queries and issues

  1. Other responsibilities (if assigned)
  • Render support for timely release of bulk BDS and resolution of BDS release matters

  • Provide QO related Impact Assessments for Change Controls and own Change Controls (relating to Quality Operations.

  • Approve SOP related to manufacturing and/or facility engineering team

  • Lead/Participate in routine GMP walk-through with manufacturing and/or facility engineering team

  • Participate in all process improvements/studies with Technical Services and the manufacturing team and draft test scripts/ protocols

  • Proper and timely archival of QO documents

  • Manage Cell Bank and BDS Retention Samples

  1. Leadership
  • Build strong partnership with all other departments to ensure open communications and acceptance

  • Commitment to a fair and respectful relationship to others and behavior in accordance with Shire’s Code of Conduct

5 .Responsibility to adhere to any applicable EHS requirements.

  1. Commitment to a fair and respectful relationship to others and behavior in accordance with Shire’s Code of Conduct.

  2. Any other duties as assigned by supervisor.

Education and Experience Requirements

  • The candidate should have at least a degree in pharmaceutical sciences, life sciences, biology, biotechnology chemistry, chemical engineering, or a related discipline. Additional certification and trainings such as auditor training or QP training will be advantageous.

  • A minimum experience of 2 years in the pharmaceutical or biotechnology in quality assurance, GMP/GLP compliance, manufacturing operations or validation, ideally in a multinational company. Hands-on experience with upstream (e.g cell culture, cell expansion, fermentation, media preparation etc), downstream (e.g purification, column packing, etc) will be advantages.

  • Understanding of FDA/Eu cGMP and ICH guidelines, any exposure/experience to the international regulatory network will be advantages.

  • Able to logically solve problems in order to find timely solutions.

Key Skills and Competencies

  • Ability to build good partnership

  • Good knowledge in the various regulatory requirements

  • Product Release knowledge is preferred

  • Able to logically solve problems in order to find timely solutions.

  • An ability to interact and communicate with all types of personalities in an effective and diplomatic manner

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.