Back to Open Jobs Positions

QA Operations Specialist

GenIbet’s core activity is the manufacture and supply of materials for use in early stage drug development, pre-clinical studies and cGMP manufacturing for Phase I and II clinical trials.

Profile:

  • Masters’ degree in Pharmacy, Chemistry, Biotechnology, Biochemistry, Chemical Engineering, or equivalent
  • GMP knowledge
  • FDA experience preferred
  • Process engineering and pharmaceutical production experience
  • Minimum 5 years of work experience in the pharmaceutical industry, particularly in quality assurance related fields.
  • Batch record Review experience
  • Knowledge of Data Integrity principles and Risk Management tools
  • Analytical skills, proactive and creative personality
  • Ability to multi-task, work independently, be self-directed and organized
  • Comfortable working in a fast-paced and dynamic work environment
  • Team working and multi-disciplinary approach ability
  • Good communication skills
  • Good English level (written and oral)

Main Responsibilities:

  • Implement and enforce Quality Management System application in the context of more complex projects (e.g. chromatography, Sterile DS/DP), assuring that production operations are clearly defined and implemented, and that each batch is produced and controlled in accordance with the requirements of the Good Manufacturing Practice
  • Work with Project Managers, in the context of complex projects, to define and approve production processes, final product specifications and documentation according to Quality Management System, as well as final product analysis, communicate with clients and make decisions on how to ensure conformity with the defined guidelines and Quality Agreements
  • Analyse Deviations and Out of Specification (OOS), ensuring an investigation is conducted to find out their root causes, and that their impacts on the product/ project are evaluated and reported, taking measures to anticipate, prevent and correct them
  • Define corrective and preventive actions in projects to address non-conformities and enforce guideline follow through, including discrepancies, reprocessing and rework procedures
  • Revise projects and production operations’ reports and documentation to verify if the production process followed internal procedures and Good Manufacturing Practice, and forward conclusions to the Qualified Person.
  • Ensure, in close collaboration with QA Systems’ team, the revision and approval of Standard Operating Procedures (SOPs), so that they are duly issued and their last version is available and at use.
  • Enforce and supervise the validation of processes, guaranteeing validations are well executed and in compliance with Good Manufacturing Practice
  • Issue and approve Customized Assemblies Manufacturing Instruction (CAMIs)
  • Supervise the revision and approval decision of new or edited documents related with internal policies, procedures, work instructions, protocols, test methods and specifications, following the procedures in place
  • Collaborate with Quality Control to make sure there are facilities, resources and infrastructure to guarantee that the product is stored and dispatched to the customer, in order to maintain its quality during shelf life
  • Collaborate with Quality Control to make sure that materials for the manufacture and packaging of the products are accurate, all necessary controls are carried out for product and/or intermediates, and that the remaining in process controls and validations are performed
  • Provide team members guidance and technical support regarding the different types of projects, according to their complexity and the level of autonomy and experience needed, and supervise training activities, guaranteeing they follow internal procedures and comply with the established guidelines and Good Manufacturing Practice
  • Track and keep up to date with national and international legal and regulatory requirements and good pharmaceutical manufacturing practices, making sure all the relevant parties are informed, including the management team.

Apply to QA Operations Specialist

    Processing my personal data

    I authorize GenIbet to store the data I have provided for the purpose of responding to my contact request. The information I am providing will be stored in accordance with our Privacy Policy and with data protection regulations.

    Definições de Cookies

    Genibet may use cookies to memorise the data you use when logging to Genibet website, gather statistics to optimise the functionality of the website and to carry out marketing campaigns based on your interests.

    They allow you to browse the website and use its applications as well as to access secure areas of the website. Without these cookies, the services you have requested cannot be provided.
    These cookies are necessary to allow the main functionality of the website and they are activated automatically when you enter this website. They store user preferences for site usage so that you do not need to reconfigure the site each time you visit it.
    These cookies direct advertising according to the interests of each user so as to direct advertising campaigns, taking into account the tastes of users, and they also limit the number of times you see the ad, helping to measure the effectiveness of advertising and the success of the website organisation.

    Required Cookies The cookies allow to customize the commercial offers that are presented to you, considering your interests. They can be our own or third party cookies. Please, be advised that, even if you do not accept these cookies, you will receive commercial offers, but do not match your preferences.

    Functional Cookies The cookies offer you a more complete and personalised experience, allowing to safe preferences, showing you relevant content to your liking and send you alerts you have requested.

    Advertising Cookies These cookies offer the possibility to connect to social media and share content from our website.