Shire QA Sr Specialist I in Woodlands Industrial Park (Baxalta), Singapore

Primary Objectives of this Job

This position is part of the Quality Assurance team responsible for implementation and maintenance of the various Quality Systems and/ or incoming material release to achieve the site objectives for Shire Singapore.

Responsibilities

General responsibilities:

  • Participating in investigations relating to laboratories/ incoming material release/ systems and review/approve the investigation report.

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

  • Reviewing/approving change controls and SOP for supporting areas

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

  • 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

  • EHS

  • Responsibility to adhere to any applicable EHS requirements

  • Any other duties as assigned by supervisor.

Other responsibilities:

  • Quality System(s) implementation and maintenance (if assigned)

  • Participate and lead in Quality System(s) rollout by ensuring that the following elements of the assigned Quality System(s) is/ are implemented and maintained at the site according to regulatory, corporate and division requirements:

  • Nonconformance/CAPA, Change control, , Incoming Release, , Quality Management Review, Customer complaints, Annual Product Review/Product Quality Review, Product Recall,

  • Owns and conduct training for the (why QA Spec II does not have ‘applicable’ and ‘assigned’ quality system(s) (e.g, TrackWise 8 for Change Control,) and support any upgrading initiatives of this / these system(s) by corporate/division.

  • Track and monitor metrics related to assigned quality system(s) and drive performance on site.

  • Participating in investigations relating to supporting areas (e.g. laboratories/ raw material release/ systems/ warehouse) and review/approve the investigation report. Note that support areas can be subjected to changes.

  • Manage Quality Councils and Quality Management Reviews

  • Perform assessments and tasks related to change controls pertaining to Quality System

  • Responsible for development and writing of Quality system(s) and QA related procedures for assigned quality system(s)

  • Ensure timely investigation and report for customer complaints and Product Recall

  • Lead and work with the various departments to ensure timely completion of Product Review/Product Quality Review

  • Incoming Material release (if assigned)

  • Responsible for the development and writing of QA related procedures as well as incoming material specifications.

  • Ensure timely release of incoming material

  • Participating in investigations relating to laboratories/ incoming material release/ systems and review/approve the investigation report.

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 4 years in the pharmaceutical or biotechnology in quality assurance, GMP/GLP compliance, operations or validation, ideally in a multinational company.

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

  • Demonstrated ability to collaborate with cross functional or cross sites to achieve objectives.

  • Six Sigma Greenbelt training would be helpful.

Key Skills and Competencies

  • Quality systems/ incoming material release knowledge

  • Good knowledge in the various regulatory requirements including Compendia requirements

  • 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.

  • Presentation skills for training and audits and Senior Management

  • Project Management skills is preferred

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.