Supplier Quality Assurance

Location Netherlands
Discipline: Pharmaceutical
Job type: Permanent
Contact name: Beata Wydurska

Contact email: b.wydurska@panda-int.com
Job ref: 16231
Published: 4 days ago

For a multinational pharmaceutical company, I am looking for an enthusiastic Supplier Quality Assurance to ensure that all products or materials supplied are manufactured, packaged, analysed and distributed in conformance to company and regulatory guidelines and meet both internal and external customer demands.

 

RESPONSIBILITIES

  • Reports to the Director, Supplier Quality Assurance for External Manufacturing (Animal Health) and is a member of the Quality External Manufacturing team. Receives guidance and direction when necessary; discharges all responsibilities independently.
  • Performs due diligence and qualification audits to determine suppliers to be selected for the restructuring program. Reviews and approves process validations and equipment qualifications as needed to support multiple product transfers.
  • Assures that the external partner operates within the agreed upon GMP policies and procedures (or other applicable regulations) and in accordance with the Quality elements of the Commercial Agreement and the Quality Agreement. Ensures the Quality Agreements are kept up to date and ensures review of the Quality elements in the Commercial Agreement.
  • Acts as a Quality Assurance point of contact for defined key suppliers and as the Quality liaison between the external partner and the internal company personnel.
  • Supports audit plans and effective execution of subsequent remediation by the partner for observations identified.
  • Conducts regular site visits to support training and coaching to initiate quality improvements within the partners’ operations where necessary.
  • Assures quality requirements on change proposals submitted by the partners conform to all requirements.
  • Reviews all deviation investigations submitted by the partners and supports further investigation where necessary.
  • Support Product Quality Complaint (PQC) investigations with the relevant suppliers
  • Support technology transfer projects for the relevant suppliers
  • Assures guidance is provided to the partner in the preparation of quality systems, procedures and guidelines as applicable
  • Support effective preparations at the external party for regulatory inspections (where required).

 

PROFILE

  • Bachelor’s degree in Veterinary, Chemistry, Pharmacy, Biology, Microbiology, Chemical Engineering, or equivalent
  • Must have expertise and broad experience in Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements
  • Must have English language capability preferably with a second language
  • Must have excellent problem-solving skills, based on science, facts, data and understanding of the regulatory requirements in complex and evolving environments; must be able to apply sound risk management principles
  • Must have the ability to influence management of complex manufacturing operations, protecting company image and reputation with patients, medical stakeholders and regulatory agencies.
  • Must have expertise in interdisciplinary areas of pharmaceutical sciences, analytical chemistry, microbiology, sterile operations, cGMPs and regulatory issues
  • Must have the ability to work independently with limited supervision in a virtual-management environment.
  • Must have strong demonstrated interpersonal, communication, negotiation, persuasion and leadership skills in dealing with a broad variety of cultures on non-routine matters in stressful situations. Able to handle organisational complexity and ambiguity

HOURS
40 hours a week

DURATION
Permanent

LOCATION
Europe time zone + 50% travel Europe (mainly Italy + The Netherlands + Germany France + India rarely or not at all) (if necessary, to meet with the team and local CMOs)

 

Interested?

If you are interested in the above description, apply with your CV

PS: Did you also know that we offer an attractive referral scheme?

For more information, please contact Beata Wydurska on +31 (0) 20 20 44 502 or B.Wydurska@panda-int.com