Quality Compliance Specialist (9 month fixed term contract)

Shire (Neuchâtel NE, Schweiz) Vor 15 Tagen veröffentlicht

Takeda Neuchâtel

Site de Production Biotech | Biotech Manufacturing Site

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine.

Here, everyone matters, and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.

An exciting and challenging opportunity has become available at Takeda’s Neuchatel Manufacturing plant (approx. 650 employees) for an experienced…

Quality Compliance Specialist (9-MONTH FIXED TERM CONTRACT)

About the Role:

This position is part of the Quality Compliance department for activities related to regulatory and quality compliance in the Neuchâtel site. The main objective is to contribute to the maintenance and improvement of site compliance with international GMPs and regulations, and company requirements.

Function/Specific competencies

Readiness Program:

  • Provides the KPIs linked to the adherence to the Risk Register and GMP Audits
  • In collaboration with the Quality Compliance Expert, coordinates Inspection Readiness Gap Assessments

External inspections and internal audits (Corporate)

  • Organizes the preparation of inspections
  • Coordinates the preparation of pre-required documents
  • Prepares the Inspection Preparation Plan (external inspections)
  • Prepare in collaboration with the Quality management the opening presentation for inspections where required
  • Organizes logistics (rooms, computers,…)
  • Define and enroll the inspection team in collaboration with the Quality Compliance manager and the Site Leadership Team
  • Trains the audit team on what their role in the inspection involves
  • Initiates response forms and corrective and preventive actions
  • Proposes different strategic options for the answers to observations inpectors’ concerns
  • Participates in response development, and plans for corrective and preventive actions
  • Updates all records relating to inspections in Track Wise
  • Ensures timely completion of answers to observations/concerns and of associated corrective actions
  • Proposes actions for simplification and improvement in the areas described above
  • Perform renewal and requests of GMP Certificate and Marketing Authorization provided by Swissmedic.

Management Review:

  • Prepare and analyze indicators that are related to the compliance activity
  • Propose improvement actions in case of indicators showing underperformance

General:

  • Provides Compliance Support to Partners including coaching
  • Participate in the deployment of the QMS integration
  • Participate in the continuous update of the Quality Compliance SharePoint
  • Participate in activities linked to the introduction/submission of new products
  • Prepares presentations and presents topics at the monthly Quality Council meeting
  • For all the above activities, manage and archive files (paper files and computer folder)
  • The job holder is the back-up of the Compliance Expert in activities related to the Inspection Readiness Workbook, Data Integrity and Complaints management.

Education & Experience:

  • University degree in technical/ scientific discipline such as biochemistry, chemistry, engineering or equivalent
  • At least 5 years of experience in the biotechnology and/or pharmaceutical industry, preferably both
  • Experience as an auditor for internal inspections or for GMP inspections is a plus
  • Fluent in English and French

Knowledge Skills & Abilities:

  • Good knowledge of FDA, EMA, ICH regulations and Quality system standards.
  • Experience as a Change owner or project leader.
  • Knowledgeable in inspection against regulatory / Quality standards.
  • Knowledge/Experience with Quality tools such as Trackwise.
  • Good analytical skills and ability to simplify the complex.
  • Solution oriented.
  • Good listener and communication skills.
  • Good organizational skills and continuous improvement mind.
  • Team player, reactive and flexible

Living our leadership behaviors is a basic expectation for all Takeda employees.  Takeda expects all employees to embody the following:

Leadership Behaviors

  • Be Positive
  • Be Accountable
  • Be Results Oriented
  • Be An Excellent Manager of Self and Others

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, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda 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, a wholly-owned subsidiary of Takeda 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.

Quality Compliance Specialist (9 month fixed term contract)

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