Quality Assurance Manager

Hiring By - Biostaffic

 BioPharma

Spain

Job Highlights

Not Disclosed

Posted 4 months ago
Job details

APICES is a CRO in the pharmaceutical sector. It offers services in the field of clinical research both nationally and internationally providing support in the development of research projects.

The ideal candidate is a critical thinker who will proactively will be responsible for the maintenance of the APICES quality system and will lead Good Clinical Practice compliance audits including, but not limited to, clinical research sites, service providers and internal systems and processes. In addition, this position is responsible for preparing for inspections by regulatory agencies and will also participate in process improvement programs, and interaction with key partners to obtain constructive feedback.

Responsibilities

  • Identify potential risks before they become a problem, focusing on root cause analysis and preventive action
  • Build a strong team through coaching, mentoring, specific training and performance evaluations
  • Writes and develops of quality documents to maintain up to date quality systems which meet the applicable SOPs.
  • Reports and follows-up on any quality deviations/non-conformities.
  • Coordinates training program within the company.
  • Management, coordination and participation in regulatory authority inspections.
  • Management, coordination and performance internal and external audits according to audit plan and SOPs.
  • Prepare audit reports and CAPA plans.
  • Check that planned activities have been carried out and thus ensure compliance with the quality system of each department.
  • Identifies training requirements and prepares and develops an adequate training plan.
  • Provides SOPs and QA training.
  • Maintains global consistency of compliance programs and advice to all the departments.
  • Ensures SOP compliance elaborating the tools for an adequate follow up.
  • Reviews Project/Study Plans, Clinical Study Reports, Data Management Plans, Informed Consent Forms and any other relevant research-related documents for accuracy and compliance.


Experience

  • Knowledge and previous experience in clinical research and CRO environment
  • GCP and GxP
  • Quality assurance activities and ISO 9001:2015.


Qualifications

  • Bachelor's degree or equivalent experience in Health Sciences
  • 4+ years' relevant work experience
  • Highly organized with excellent attention to detail
  • English

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No

Location:

  • Spain

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 15, 2024
Company Overview
APICES
APICES

Current Openings: 0

Founded by a group of highly qualified people with a vast experience in CROs and pharmaceutical companies, APICES is a company with Spanish identity and an international vocation. APICES is not only a CRO, but a Company giving an added value to customer in study design, clinical development planning and successful regulatory timelines to achieve customers milestones. APICES offers to customers (e.g., pharma, medical devices, biotech, veterinary products companies, cooperative groups, investigators, public research organizations) clinical research services to improve the quality of investigational products development (e.g., drugs, medical devices, food supplements, advanced therapies, nuclear medicine, radiotherapy, biotechnology, veterinary products) optimizing the processes and activities of clinical research. We apply tools from field-tested technologies and with our experience and resources we are able to manage programs of any size in the most efficient way. APICES provides a full range of services from project design through to the publication of results, with expert project management to avoid and anticipate with contingency plans any possible deviation from the original project goals. We offer: - Clinical trial services, processes and innovations according to customers needs. - An experienced team who understand the objective and the aim of the project, and the importance to comply with timelines. Most of our employees have more than 12 years of experience in Clinical Research field. - Global resources at the same CRO: clinical operations, regulatory, safety, data management, biostatistics and quality assurance. - 'Know how' & 'Know who' in several therapeutic areas. - We are focused on our customer`s needs and their success, we adapt our team and resources to the customers needs and goals in local or international studies. - We work under the highest industry quality standards to ensure we meet regulatory and client requirements.
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