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QA Specialist - temporary 12 months

ID:  1498
Date of Posting:  Apr 1, 2025
Business Area:  Quality
Job Type:  Direct Employee
On site / Remote / Hybrid:  On Site
Location: 

Basel, CH

Territory: 
Full-Time or Part-Time:  Full Time
Seniority:  Associate

With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical company, listed on the Italian stock exchange, with over 4,500 employees and turnover of over Euro 2bn.

We are a group of like-minded, passionate individuals who go to extraordinary lengths for our patients, customers, partners, 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.

Job 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 head of GDP Commercial, the GDP QA specialist will be in charge of managing the GxP quality processes, with a focus on GDP.  The individual will ensure these processes are kept up to date at all times. This will include the maintenance of various documents in the eQMS and administrative training activities. Other duties might be assigned to the GDP Commercial Specialist in order to assist the other GxP areas of the quality system. The role holder will be based from our offices either in Hemel Hemsptead in UK or Basel in Switzerland on a hybrid basis.

Key Responsibilities

1. 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.
2. 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.
3. Product Return Process
• To manage the return process in conjunction with the client service 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.
4. 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.
5. Trainings database administration
• Ensure that new employees are appropriately trained to the eQMS and create appropriate access accordingly
• Inactive employees when leaving the company
• Maintain the self training desk up to date and record new training if required

Required Education

  • Degree qualified in either pharmaceuticals, biotechnology, or science related subject. 

Required Skills and Experience

  • 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. 
  • 3- 5 Experience within the pharmaceutical or 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).

Technical Competencies

Required Behaviours and Competencies

Required Languages

  • English fluent written and spoken

Travel required in %

At Recordati we believe in people! Inspired by our purpose - unlocking the full potential of life - we are committed to creating a diverse environment and cultivating a culture of inclusion. We strive to continually lead with our values and beliefs, enabling our employees to bring their whole selves to work and develop their potential.

We are proud to be an equal opportunity employer. We recruit, develop and reward without regard to, amongst others, gender, sexual orientation, gender identity or expression, national origin, age, physical or mental ability, race, ethnicity, political or religious belief.

If you are looking to join a company where you can try new things, speak openly, and be bold, we invite you to apply today.

Apply now »