QA Manager GMP

QA Manager GMP

Santhera Pharmaceuticals

Basel, Switzerland

Scope of Work:

The role reports to the GMP Compliance Officer who is based in Pratteln, and will collaborate closely with other functions such as Supply Chain, Technical Development and Regulatory Affairs based in the HQ in Switzerland and, externally, will collaborate with contract manufacturers.

The core responsibilities are (not exclusively):

  • Performance of QA operational activities (e.g. batch review);
  • Maintenance and improvement of GMP/GDP Quality Management System;
  • Vendor audits in the GMP/GDP field;
  • Internal Audits;
  • Management and evaluation of change controls, deviations, complaints, CAPA;
  • Support of HA inspections and follow up, incl. preparation of CAPA;
  • Supporting GDP activities at SPLI, as requested;
  • Supporting GMP activities at SPDE, as requested.

The responsibilities for this role include the following:

  • Act as deputy of Responsible Person Switzerland and Responsible Person Liechtenstein;
  • Review and approve executed batch production records, CoAs, stability and validation protocols and reports, as required;
  • Revise SOPs as required;
  • Prepare and review quality agreements with vendors and customers;
  • Support qualification and oversight of vendors and customers;
  • Track, evaluate and follow up on CAPA, deviations, complaints and changes;
  • Evaluation of Product Quality Reviews;
  • Communication with internal and external customers as required;
  • Support maintenance of audit plans and documentation;
  • Preparation and performance of internal and external audits;
  • Support preparation of HA inspections and CAPA responses;
  • Support computerized system validation at Santhera;
  • Support monitoring of legal requirements;
  • Support KPI evaluation;
  • Support SOP maintenance as required (formal review, issuing, uploading in LMS etc.);
  • Write and review of CMC parts of regulatory submissions.

Required background and experience:

  • University diploma in Natural Sciences or equivalent;
  • Minimum 8 years of experience in a regulated environment (pharma, medical devices or tutritionals);
  • Minimum 5 years of experience in a GMP area, preferably in QA/QC;
  • Minimum 2 years of experience in QC lab in GMP environment is a plus;
  • Good understanding of pharmaceutical manufacturing processes, quality control testing methods and quality system requirements;
  • Experience in handling regulatory inspections is a plus;
  • Fluency in German and English is mandatory;
  • Experience in CMC technical writing is a plus;
  • Qualification as EU QP not required but would be a plus;
  • Auditing experience (certification by a recognized body is a plus).

Required competencies and skills:

  • Excellent communication and interpersonal skills;
  • Team player, able to work independently as well as on cross-functional teams;
  • Excellent time management;
  • Very well structured, organized;
  • Flexible in adapting to changing priorities and deadlines;
  • Attention to details, dedication to accuracy;
  • Reliable and with high sense of accountability;
  • Self-motivation, proactive attitude, solution oriented;
  • Personal resilience, perseverance, energy and drive.

Apply Now

Don't forget to mention EuroPharmaJobs when applying.

Share this Job

© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

Newsletter | Recruit | Advertise | Privacy | Contact Us

© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

This website uses cookies to make your experience better. Continued use of this website means you accept our cookie policy.  Accept Cookies