Affiliate quality operations analyst pl – São Paulo/SP

São Paulo
Temporário
Biólogo
Bioquímico
Farmacêutico

How You Will Achieve It

• Product Quality Complaints Management
  • Evaluate if the report represents a product quality complaint.
  • Perform follow up contact with the Intake group and/or the complainant to obtain the necessary and relevant information to process the complaint.
  • Intake and Triage of complaints from the local market(s), assign class and criticality to the product complaint and forward them to the appropriate investigating PGS /Contractor Site(s) via the global complaints management system.
  • Support the management of the complained samples, including the tracking of the samples.
  • Develop and issue response(s) to the complainant in a timely manner, when required.
  • Support the activities related to the management of the Offline Contractor Site(s) investigations in the global complaints management system (investigations conclusion in the system).
  • Sustain additional and complementary alignments and trainings with the involved team(s)/department(s).
• Product Quality Incidents Management
  • Identify deviations from Product Quality and Compliance requirements that occur within the responsibility of the PCO(s) organization and initiate the incident´s investigation.
• Product Quality System
  • Support timely implementation of all applicable Product Quality SOPs within the PCO(s) and its impact in the SCQ activities.
  • Support adjustment/enhancement to local systems and processes, when required.

Qualifications

• Must-Have
  • Bachelor´s Degree in Biologics Sciences or equivalent (Pharmacy, Biochemistry, etc.)
  • Minimum 2-3 years working in pharmaceutical or related industry, preferably in Quality Operations and/or in activities related to Product Quality Complaints (Medical Information, Pharmacovigilance, etc.) and/or Product Disposition.
  • Intermediary/advanced English and Spanish language communication verbal and written.
  • Appropriate technical experience to manage expectations
  • Knowledge of the regulatory GDP/GMP compliance issues relating to manufacturing and distribution of medicinal products
  • Excellent organization skills and the ability to manage multiple priorities
  • Good collaboration, communication and interpersonal skills with local, regional and global colleagues
  • Proficiency in using System Application and Products, Microsoft Word, Excel, Power Point, Visio
• Nice-to-Have
  • Master’s degree
  • Relevant pharmaceutical experience
  • Experience with Electronic Quality Management Systems in pharmaceutical industry