GDP Quality Supervisor
GDP Quality Supervisor
Reporting to the GDP Quality Manager (Deputy RP) the Quality Supervisor is responsible for ensuring compliance with EU Good Distribution Practice (GDP) Guidelines 2013/C 343/01 under the GWWO Wholesale Distribution Authorisation (WDA).
The successful candidate will be expected to contribute to the continuous improvement of the Grifols Worldwide Operations Ltd. (GWWO) Quality Management System.
The GDP Quality Supervisor will assist in ensuring compliance to the Manufacturers Authorisation where it is impacted due to distribution activities and the receipt and storage of plasma and fractionated paste.
The successful candidate must be flexible for travel as this maybe required from time to time for business needs.
The successful candidate maybe required to be listed as a Deputy Responsible Person (DRP) on the GWWO WDA depending on business needs.
What your responsibilities will be
- Assist in the creation of Standard Operating Procedures (SOP's) in relation to the Documentation System for GDP impacting areas.
- Communicate with cross functional departments to ensure continued support of compliance under the WDA.
- Ensure GDP deviations are appropriately investigated.
- Communication with the manufacturing and distribution sites of Grifols in relation to QMS activities where appropriate and in the event of any escalation. Additionally communicates with customers of any changes that may impact Quality Agreements.
- Support compliance with the general conditions of Wholesale Distribution/Manufacturing Authorisations, guidelines and other legal requirements.
- Preparation and review of SOPs/documentation in the GDP area
- Co-ordination of customer complaints in relation to GDP
- Preparation and coordination of GDP related KPIs and Metrics.
- Ensure staff operating in GDP areas, are competent and trained initially and continuously in GDP related activities.
- Delegated tasks relevant to the site temperature monitoring including monthly reviews, review of calibration certificate of temperature monitoring probes and assist in the event of any temperature excursions within the GDP impacting areas.
- Ensure the GDP Quality Manager is appraised on all quality related issues relating to GDP
- Provide support to the GMP area as required.
- Ensure Bona Fides are maintained and periodic review is complete for Suppliers and Customers.
- Approval of new customer accounts to be created on SAP.
- Self-Inspections under the WDA as delegated by the Technical Director or GDP Quality Manager.
- Performance of audits on outsourced providers and customers as directed by the GDP Quality Manager.
- Assist with the qualification of subcontractors and recommend for approval to the Technical Director and / or GDP Quality Manager
- Liaise with Affiliates and third party distributors for any Distribution Quality related issues.
- Liaise with other Grifols sites in order to continually improve the integrity of the Grifols supply chain, which includes creation of procedures, management of Quality Agreements and attending global meetings if deemed necessary as directed by GDP Quality Manager.
- Manage any direct reports in the Grifols GDP Quality team, ensuring they are appropriately trained and have received delegated tasks.
- Assist the RP and DRP in the review and coordination of returns of medicinal products to GWWO
- Ensure Plasma and Fraction Paste is received, stored and shipped in a compliant manner.
- Assist the Technical Director / GDP Quality Manager in the event of any recalls
- Cover for the GDP Quality Manager in the event of any absences onsite.
- Coordination of Customer Quality Agreements from a GWWO perspective.
Who you are
- Excellent people and time management skills
- Strong technical writing and analytical skills
- Excellent communication and teamwork
- Ability to work proactively on own initiative
- Ability to make decisive decisions and escalate where required
- SAP Pharma experience preferably
- Experience and understanding of a QMS
- Understanding and experience of EU/GDP GDP Requirements
- Experience working in distribution/manufacturing and supply chain experience in the pharmaceutical or related industry working under quality management systems in an environment of continuous improvement.
- Experience of working in a team environment and participating in Team Projects.
- Experience working in a multicultural environment
- Previous experience of managing a team or direct reports.
- Degree in Life Science, Biological Sciences or Pharmacy / Pharmaceutical related discipline.
Information about Grifols is available at www.grifols.com. If you are interested in joining our company and you have what it takes for such an exciting position, then don't hesitate to apply!
We look forward to receiving your application!
- Grifols is an equal opportunity employer.
- Level 6
- Flexible schedule
- Benefits package
- Contract of Employment: Permanent position
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