Quality Assurance / Regulatory Affairs Manager

GENERAL POSITION SUMMARY

Lallemand Pharma is a Swiss company based in Lugano, Ticino, Switzerland dedicated to the production and marketing of medical device and pharmaceutical product.

We are looking for a candidate that will endorse the role of Quality and Regulatory Affairs manager, being responsible for the day-to-day maintenance of Quality Management System (QMS) performing Procedures (SOP) updates and all necessary operatives follow-ups related among others to Nonconformities, Change Control, CAPA, Complaints and feedbacks with our customers and manufacturing plants. The candidate will also participate in internal, authorities and suppliers’ audits.

She/he will also oversee the regulatory watch for the company reporting to Quality and Regulatory Affairs manager for gap assessments, preparation and simple modification of products’ technical documentation and will participate to regulatory support to our customers.

Location: Massagno, TI (Switzerland)

Starting date: Q1 2023

Salary: To be discussed

 

PURPOSE OF ACTIVITY:

The candidate will report directly to the Regulatory Affairs & Quality Assurance (RA/QA) manager.

Her/his main tasks will be as follows: Quality Assurance (QA) Manager

• QMS Documentation – procedures, processes, manuals, templates

• Quality Management System (QMS) monitoring o Follow-up the revision history of QMS documents to insure system consistency o Support the update of all Standard Operating Procedures (SOP) and Records (REC) of the QMS o Ensure that all operative documents are in line with the QMS and properly archived into the system o Follow-up changes, complaints, CAPA, deviations managed under QA manager supervision

• Support Auditing services for supplier and sub-supplier compliance with quality, regulatory, standards, and related requirements

• Customers relation support o Ensure the timely processing of customer complaints and claims

• Support the RA/QA manager with any customer request Regulatory Affairs Manager

• Involved in writing and update of medical device technical files or pharma products regulatory dossiers under the supervision of the Regulatory Affairs (RA) manager

• Helps to maintain certifications in place

• In charge of the regulatory watch performance and report based on standards and norms applicable to the activity of the client

 

REQUIRED SKILLS:

Knowledge

• Master’ degree with specific additional training in Quality Assurance or Regulatory Affairs

• Knowledge of Pharma and Medical Device regulatory legislation

• A first experience of at least 5 years in a similar position required Skills

• English (fluent). Italian and/or French will be a plus

• Computer skills (Pack Office) Attitude

• Rigorous, Analytical mind

• Team-player

• Autonomous

• Good Communication skills (verbal and written).

 

Please send your CV at officelp@lallemand.com

Website: www.lallemandpharma.com