Quality Assurance Specialist Loures

Join to apply for the Quality Assurance Specialist role at Hovione.

Hovione is an independent family‑owned international group of companies dedicated to helping pharmaceutical customers bring new and off‑patent drugs to market. With over 1950 team members worldwide, we focus on innovation and excellence.

Responsibilities

• Guarantees c
  GMP compliance in all activities and systems related to Projects and Products execution.
• Assures that working practices are streamlined and aligned with the actual needs of each project.
• Implements policies, procedures and methods to evaluate and continuously improve the quality of products and operations throughout the products lifecycle.
• Provides global supplier qualification services in support of new product introduction and existing products.
• Collaborates with suppliers and Procurement to assure the quality of their products, materials, components and/or operations.
• Rigorously, accurately, efficiently and professionally manage all quality activities for the assigned projects and/or products in accordance with applicable c
  GMP, quality operational standards / procedures and legal regulations, ensuring the site is always “audit ready”.
• Promote the importance of high‑quality levels and a continuous improvement culture in relevant company activities.
• Act as a catalyst for change and improvement in performance/quality.
• Assigned projects may relate to any of the following (non‑exhaustive) areas: 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, Customer requirements, PQR.
• Provide an example of professionalism and support the induction and training of new colleagues within the area.
• Efficiently, accurately and reliably ensure that project and/or product activities are delivered in compliance with c
  GMP requirements and maintenance of the company Quality Management System is assured.
• Manage and participate in Quality Product key activities for the assigned product/projects, and introduction of new products; including preparing, reviewing and approving auxiliary documentation, protocols and quality related reports.
• Prepare for and support internal and external site audits and inspections, conducting regular reviews and periodically following‑up action plans as necessary.
• Ensure inspection readiness in work completed and act in an advisory capacity for all internal and external site audits.
• Periodic follow‑up of ongoing deviations and Pd
  As to assure timely closure of deviations and approval of Pd
  As, as appropriate.
• Close open deviations and propose CAPAs based on the outcome of periodic follow‑ups.
• Prepare SOPs, department IOPs, quality related reports, revision of executed batch documentation and change control documents (Pd
  As) as required and appropriate.
• Approve IOPs, process master documentation and product specifications as required and appropriate.
• Ensure that SOPs and IOPs are up to date, compliant and support efficient production.
• Review regulatory documentation and coordinate site documentation to support regulatory requirements.
• Authorize the usage of production equipment/utilities when qualification required.
• Solve challenges related to compliance problems by providing collaborative and timely support to all areas and departments, escalating as required.
• Ensure the effective and proactive flow of information between stakeholders, representing the team as appropriate.
• Assure and promote compliance on Health, Safety and Environment in the area and activities for which is responsible, or in which participates.
• Maintain a regular presence on manufacturing floor, providing on‑the‑job support, developing a sense of collaboration with operational areas and performing a general oversight of activities, as required.
• Approve Validation Master Plans, Process Validation Protocols and reports as required.
• Accurately use and maintain all information systems.
• Support the generation/reporting of KPIs for the team.
• Develop and accumulate strong QA expertise, sharing knowledge of new developments and methodologies within the area.
• Coordinate and assist with the analysis and investigation of customer complaints that may arise; ensuring all complaints are investigated and closed out within specified timeframes.
• Provide relevant training to new colleagues, and to the other areas in applicable c
  GMP, internal procedures and quality systems in accordance with established training plans.
• Be an advocate for safe operating and high‑quality performance, alerting ascending colleagues to any potential risks, discrepancies, deviations or non‑conformance in accordance with Hovione internal procedures, suggesting optimizations or improvements.
• Ensure all assigned tasks are planned and delivered on time, safely, efficiently, reliably and in a cost‑effective manner.
• Propose improvements to the area as appropriate and solve problems.
• Make quality and timely decisions within the Quality Assurance tasks under her / his responsibility.
• Gather relevant data to inform the decision makers regarding complex issues.
• Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione’s policies, systems and procedures (COPs, HBR, SOPs and others).
• Undertake any additional tasks commensurate with the role as and when required.
• 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.

Required Qualifications

• University, or equivalent, qualification in Chemistry, Chemical Engineering, Pharmaceutical Sciences or similar scientific field (mandatory).
• Typically requires 3-5 years of relevant experience in a QA GMP environment within the Pharmaceutical Industry (highly desirable).
• Experience of working in a GMP operational environment (mandatory).
• Training and experience of GMP standards (mandatory).
• Experience of working with Regulatory Affairs and a basic knowledge of the function (desirable).
• Strong understanding and knowledge of GMP practices.
• Fluency in English is a requirement.
• Computer literate with good working knowledge of the MS Office package.
• Strong documentation skills and attention to detail.

Seniority level

• Associate

Employment type

• Full-time

Job function

• Quality Assurance
• Pharmaceutical Manufacturing

Hovione is a proud Equal Opportunity Employer. Inclusion and diversity are key to us. We value a work environment where differences are respected and everyone is treated fairly, regardless of age, gender, religion, disability, sexual orientation or ethnicity.