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Complaints & Distribution Lead -industrial Division

3 months ago

Hemel Hempstead, Hertfordshire, United Kingdom Recordati Group Full time

With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical force, listed on the Italian stock exchange, with over 4,300 employees.


We are a group of like-minded, passionate individuals who go to extraordinary lengths for our partners, customers, investors and the people across the globe who we serve.

We develop and commercialise medicines to serve people living with common diseases, as well as those living with some of the rarest, in around 150 countries.

At Recordati, our mantra is simple.

We've always believed that health, and the opportunity to live life to the fullest, is a right, not a privilege.

Whether that is for common diseases or the rarest - we want to give people the opportunity to be the best version of themselves.

This drive will never stop. Together, we will always be reimagining tomorrow - with new ideas, new technologies and new innovations to fight diseases.

Recordati. Unlocking the full potential of life.

ROLE PURPOSE


The Quality Management System (QMS) at RECORDATI supports GxP activities on pharmaceutical products according to the highest standards of accuracy.


In close collaboration with the company RPs and QA team members, with the relevant departments in the company, and under the supervision of the QA Associate Director, the Complaints & Distribution Lead will be in charge of managing the GxP quality processes, with a focus on GDP, in the running of the site's Quality Management System.

The individual will ensure these processes are kept up-to-date at all times.

This will include the maintenance of the various databases (excel sheets or EQMS) and contacting internal and external stakeholders for the correct processing of the activities.


Other duties might be assigned to the Complaints & Distribution Lead in order to assist the other GxP areas of the quality system.


ROLE REQUIREMENTS

Key Accountabilities

Key Activities / Decision Areas

  • Complaints Management
  • Management of complaints system by ensuring all complaints are logged, in the company database in a timely manner.
  • Investigate complaints and complete CAPA where related to the area of responsibilities in a timely manner.
  • Monitor and coordinate any complaints investigation at Partners level.
  • Perform the monthly PV/complaint reconciliation with partners.
  • Provide Monthly complaints KPIs and Metrics.
  • Change control, deviation, CAPA and audit systems
  • Investigate deviations, complete CAPA and change control actions where related to the area of responsibilities in a timely manner.
  • To manage and file the documentation associated with these systems.
  • To ensure closure of the change controls and CAPAs in a timely manner.
  • To support the internal audit and inspection readiness processes.
  • Product return process
  • To manage the return process in conjunction with the CSO and logistics teams.
  • To ensure all return documentation is completed correctly and in line with relevant SOPs.
  • To ensure that returns are closed in time and any associated deviations or complaints are reported correctly.
  • Suppliers' qualification and customers' verification
  • To support the partners' qualification process including the maintenance of the suppliers' qualification database and the obtaining of the partners' licenses to operate.
  • To support the customer verification process and approve the verification forms when required by the RP.
  • Trends
  • To issue key performance indicators (KPIs) and create dashboards of related processes for monitoring purposes and trend analysis.
  • Stakeholders Management
  • To chair periodic meetings with internal and external stakeholders to ensure that complaints are fully investigated and reported in a timely manner.
  • To provide periodic updates on the status of GDP complaints to the company's RPs to ensure regulatory compliance.

ROLE DIMENSIONS

Quality Systems Requirements

  • Maintain an understanding of RECORDATI Pharma working practices, SOPs, GDP Guidelines and relevant country codes and ensuring these standards are met across the organisation.

Technical / Professional Expertise

  • Clear understanding of Pharmaceutical Industry environment, regulations and constraints.
  • Knowledge and experience of working to quality programs such as GMP and GDP, ideally ISO 13485 standard.
  • Experience within the pharmaceutical or medical device industry, ideally in a similar position would be an advantage.
  • IT skills specifically MS Excel and MS Word, ideally Veeva Vault. Demonstrated autonomy in the daily activity, autonomous, willingness to work in a multicultural environment interpersonal and communication skills (both written and verbal).

Personal Specification

  • Autonomy
  • Good communication and influence skills
  • Team spirit oriented
  • Build strong relationships with internal customers
  • Work with all relevant staff to maintain the smooth running of day to day operations

NOTE:
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