Quality Assurance Associate

- Rigorously, accurately, efficiently and professionally manage all quality activities for the assigned projects and / or products in accordance with applicable cGMP, quality operational standards / procedures and legal regulations, ensuring the site is always “audit ready”

- Promote the importance of high-quality levels and the importance of 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 cGMP 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 (but not limited to) preparation, review and approval of auxiliary documentation, protocols and quality related reports

- To 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 PdAs to assure timely closure of deviations and approval of PdAs, as appropriate

- To close open deviations and propose CAPAs based on the outcome of periodic follow-ups

- Prepares SOPs, department IOPs, quality related reports, revision of executed batch documentation and change control documents (PdAs) as required and appropriate

- Approves IOPs, process master documentation and product specifications as required and appropriate.

- Ensures that SOPs and IOPs are up to date, compliant and supports efficient production

- Review regulatory documentation and co-ordination of 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

- To assure and promote compliance on Health, Safety and Environment in the area and activities for which is responsible, or in which participates

- To 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

- To approve Validation Master Plans, Process Validation Protocols and reports as required

- Develop and accumulate strong QA expertise, sharing knowledge of new developments and methodologies within the area

- Co-ordinate and assist with the analysis and investigation of customer complaints that may arise; ensuring all complaints are investigated and closed out within specified timeframes

- To provide relevant training to new colleagues, and to the other areas in applicable cGMP, 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.