Shire Quality Specialist in Berlin, Germany

Posting Title Quality Specialist

Job ID 15550BR

Function Technical Operations

Division Quality

Employee Type Regular

Level SRPR I

Search Location(s) Germany - Berlin

Job Category Quality Assurance

Job Description SUMMARY :

The Quality Specialist performs technical batch release of finished drug products and supports official batch testing by Paul-Ehrlich-Institut. The incumbent will act as the local complaint coordinator for incoming product quality complaints (PQC), local change controls and deviations. He/She will perform appropriate Field Corrective Actions (FCA) and implementation in Germany in close cooperation with global functions. In this role, the successful candidate will assist the responsible person in the assessment of retuned products, review and revise quality documents (SOPs, Quality Technical Agreements, …) in cooperation with RP / QA Manager and ensure that corporate QMS and local standard operating procedures (SOP) following GDP standards are in place . The Quality Specialist will establish and maintain appropriate contacts with internal functions (e.g. Regulatory Affairs, Pharmacovigilance, Manufacturing sites, Supply Chain) and external functions (e.g. Customers, External Warehouse, Health authorities). He/ She will be responsible to train local functions on complaint handling, FCA, quality and QMS requirements.

RESONSIBILITIES:

  1. Perform technical batch release of finished drug products
  • Review of batch related documents

  • Conduct bookings in company’s ERP system

  • Clarify issues with manufacturing sites and external warehouse

2.Support official batch testing by Paul-Ehrlich-Institut

  • Upload review batch documents to Pei system

  • Act as point of contact for enquiries of the authority

  1. Act as the local complaint coordinator for incoming product quality complaints (PQC), local change controls and deviations
  • Initiate records in relevant systems (e.g. Trackwise, Veeva)

  • Follow up with customer / internal departments to assure timely closure of action items

  • Coordinate test sample shipment in case of complaints

  1. Perform appropriate Field Corrective Actions (FCA) and implementation in Germany in close cooperation with global functions
  • Ensure that a local FAC process is in place.

  • Coordinate local activities in case of necessary FCAs (e.g. Blocking of stock, Perform batch tracking)

  1. Assist responsible person in the assessment of retuned products
  • Review of documentation from customer and external warehouse.

  • Assessment of avaiable temperature date

REQUIREMENTS:

Essential:

  • Relevant University degree or equivalent qualification in Pharmaceutical Industry

  • 5+ years’ experience working in Quality Assurance or Quality Management

  • Interpersonal skills and professional skills to interact with external interfaces while representing Shire.

  • Excellent knowledge of local GDP regulations, plus good awareness of relevant GMP requirements

  • Fluent in German and good English skills

  • Experience in the usage of Microsoft Office, Outlook

  • Experience in Trackwise, Veeva, SAP is beneficial

  • Must be able to prioritize and multitask in an environment with changing priorities

Desired:

  • Experience in QA of a Marketing & Sales organization

  • Experience interfacing with regulatory bodies directly

  • High level of professional competence.

  • Good interpersonal and communication skills

  • Proactively addressing compliance issues and assuming responsibility for compliance deficiencies

  • Solves problems whilst maintaining Quality Standards and considering Shire Policy

  • Understands total potential impact and contributes to the solution of issues arising

  • Uses experience to facilitate troubleshooting, and to tackle non-routine work and projects independently

  • Offers constructive comments and proposes improvements and rationalizations to systems, policies and procedures

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.