QA manager m/f 100 %

Bern  ‐ Onsite
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Description

My client is one of the leading pharmaceutical company in the world, for their headquarter in Bern area,Switzerland I am looking for a:

QA Manager f/m 100%

Aim of the Position:
  • Ensuring that products, systems and facilities are in state of sustainable compliance with the requirements of cGMP and regulatory authorities.
  • Responsible for all quality matters related to the activities performed in the production and during process development.
  • Assure efficient and effective quality assurance activities at required cGMP level.
  • Assure that the products are manufactured according to cGMP requirements.
  • Together with the team, support operations and / or development with cGMP guidance on all strategic decisions.


Essential duties Operational:
  • Ensuring compliance of products, processes, systems and equipment with global and local guidelines and procedures as well as with legal or regulatory requirements.
  • Review and approval of SOPs, WOIs, TEIs, FOBs, RARs and other quality related documents.
  • Review and approve Raw Materials.
  • Perform batch record review and batch disposition.
  • Review, assess and approve local Change Controls.
  • Review and assess global Change Controls.
  • Review and approve event and deviation reports. Assess event and deviation reports for any need of escalation to the Manager Quality Development.
  • Ensure definition of appropriate and effective CAPAs with appropriate timelines and ensure timely implementation.
  • Ensure appropriate coverage of CAPAs by effectiveness checks, follow up their execution and evaluate the results.
  • Support Manager Quality Development in evaluation of PTCs and ADRs.
  • Review release package (including samples).
  • Review and approve certifications for Health Authorities.
  • Support in compilation of the PQRs.


cGMP compliance
  • Manage and further develop the quality system.
  • Increase cGMP understanding within ^the company including training.
  • Support inspection team during preparation, execution and follow up of inspections and audits.


Competencies Operational:
  • Review and approval of changes.
  • Review and approval of CAPAs.
  • Review and approval of investigation, events and deviations reports.
  • Review and approval of SOPs, WOIs, TEIs, FOBs, RARs and other quality documents.
  • Review an release of raw materials specification documentation.
  • Review and approval of raw materials.
  • Review of MBRs, Batch Production Records, including all supporting documentation (for example, test results)
  • Compilation of batch dossier for batch release
  • Perform QA release of batches and intermediates.
  • Set batch status in LIMS and SAP excluding QP release.
  • Take over equivalent competencies for other products if delegation approved by the qualified person.
  • Requesting for blocking of equipment, processes and products.
  • Definition of quality related corrective and preventive actions.


Requirements:
  • Min 5 years of experience in quality assurance of biological or pharmaceutical products according to cGMP requirements.
  • University degree in natural sciences, medicine or pharmacy or Professional scientific, medicinal or pharmaceutical training and several years working experience under cGMP.


Quality requirements:
  • Know how of quality assurance principles (cGMP).
  • Know how of biological manufacturing processes.
  • Profound know how of Quality Assurance.
  • Inspection experience.
  • Know how of risk management.


Management Skills:
  • Analytical thinking and problem-solving ability.
  • Communication ability and Good negotiation skills.
  • Time and self-management
  • Multilingual - at least German and English, written and spoken


Non-Technical profile requirements:
  • Some flexibility in working hours is required
  • Must be able to work on multiple simultaneous tasks with limited supervision;
  • Quick learner, motivated self-starter;
  • Excellent customer service, interpersonal, communication and team collaboration skills;
  • Able to follow change management for internal guidelines.
  • Language proficiencies: -English spoken and written;


Duration of the contract:

Immediately available until 31.12.2016 - high possibility for an extension
About me:

I am a specialised recruiter, currently taking care of various projects within the Life Science area in Switzerland. If this role is of interest to you or to someone from your network, please send your CV in Word format including your hourly rate expectation for immediate consideration.
You can reach me on or at
Start date
07/2016
From
Real Staffing
Published at
14.06.2016
Project ID:
1147713
Contract type
Freelance
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