Quality Assurance Specialist
The role of the Quality Assurance Specialist is to ensure that all analytical activities are rigorously, accurately, efficiently, and professionally managed to maintain compliance with cGMP, quality operational standards, procedures, and legal regulations. This includes ensuring inspection readiness in work completed and acting in an advisory capacity for all internal and external site audits.
* Assign and manage projects related to Raw Materials, Suppliers, Specifications, Production Processes, Change Control, Deviations, Quality agreements, Qualification and Validation, Stability Programs, Batch Release, Equipment Cleaning, Client Audits, Internal Audits, Customer Complaints, and Customer requirements.
* Ensure inspection readiness in work completed and act in an advisory capacity for all internal and external site audits, taking a lead on the most complex situations.
* Periodic follow-up of ongoing deviations and change controls to assure timely closure of deviations.
* Review regulatory documentation and coordinate site documentation to support regulatory requirements.
* Solve challenges related to compliance problems by providing collaborative and timely support to all areas and departments, escalating as required.
* Develop and accumulate strong Quality Assurance expertise, promote the importance of continuous improvement culture, and act as a catalyst for change and improvement in performance/quality.
* Rigorously, accurately, efficiently, and professionally manage all analytical activities for assigned projects and products, ensuring compliance with cGMP, quality operational standards, procedures, and legal regulations, maintaining the site in an audit-ready state, and preparing, reviewing, and approving auxiliary documentation, protocols, quality-related reports, product specifications, and process validation protocols and reports as needed.
* Coordinate and assist analysis and any other investigation, including customer complaints that may arise, and manage risk and uncertainty; anticipate and escalate roadblocks in order to prevent deviations to the goals.
* Make quality and timely decisions based on multiple sources of data.
* Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations, and codes of practice.
Requirements include a University or equivalent qualification in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or similar field; experience in QA and/or QC laboratory environment, preferably under pharmaceutical cGMP; fluency in English is a requirement; knowledge, experience, and skills to conduct and plan/organize tasks in accordance with the rules and procedures set down; knowledge of GMP and ICH practices, analytical theory, and techniques with the ability to solve complex problems; knowledge of EU/US quality-related pharmaceutical regulations; experience in conducting quality-based investigations and root cause analysis; experience of HSE rules and regulations (mandatory).
Hovione is committed to equal opportunities and diversity. The company strives to create a work environment where differences are valued, and everyone is treated with fairness and respect. All team members worldwide are supported, respected, and have the opportunity to achieve their full potential, regardless of age, gender, religion, disability, sexual orientation, or ethnicity.
Seniority level: Associate
Employment type: Full-time
Job function: Manufacturing and Analyst
Industries: Pharmaceutical Manufacturing