Senior Quality Assurance Specialist

Hovione

Jan 25

Applications are closed

Job
Full-time
Senior Level
Research & Development
Cork

Requirements

- University, or equivalent, qualification in Chemistry, Chemical Engineering, Pharmaceutical Sciences or similar scientific field (mandatory)
- Typically requires 5-8 years of relevant experience within a QA GMP environment within the Pharmaceutical Industry (mandatory)
- Experience of working in a GMP operational environment (mandatory)
- Training and experience of GMP standards (mandatory)
- Experience of working with Regulatory Affairs and a well-rounded knowledge of the function (mandatory)
- Advanced knowledge of GMP practices with the ability to solve complex problems.
- Fluency in English is a requirement
- Computer literate with good working knowledge of the MS Office package
- Advanced documentation skills and attention to detail
- Must have the Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down.

Responsibilities

Guarantees cGMP 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 to 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 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
Provide an example of professionalism and leads the induction and training of new colleagues within the area
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
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 authorize the release for sale of finished products (applicable to site without QP)
Prepare for and support internal and external site audits and inspections, leading 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, taking a lead on the most complex situations
Periodic follow-up of ongoing deviations and PdAs to assure timely closure of deviations and approval of PdAs, 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 (PdAs) 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 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
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.
To approve Validation Master Plans, Process Validation Protocols and reports
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.
Lead the development and sign-off of training materials and 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
Proactively lead the provision of support to less experienced colleagues in the undertaking of their duties
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, including those that have the potential to mitigate unnecessary complexity
Master Quality Assurance processes and tools
Manage complex projects/ analysis with significant impact on business
Make quality and timely decisions based on multiple sources of data
Manage risk and uncertainty; anticipate and escalate roadblocks in order to prevent deviations to the goals
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.

FAQs

What is the primary responsibility of the Senior Quality Assurance Specialist at Hovione?

The primary responsibility is to guarantee cGMP compliance in all activities and systems related to project and product execution, while implementing policies and procedures to continuously improve the quality of products and operations.

What qualifications are required for this position?

A university or equivalent qualification in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a similar scientific field is mandatory.

How many years of experience is typically required for this role?

Typically, 5-8 years of relevant experience within a QA GMP environment within the Pharmaceutical Industry is required.

What language proficiency is required for this position?

Fluency in English is a requirement.

What type of environment will I be working in?

You will be working in a cGMP operational environment, ensuring compliance and overseeing quality assurance activities.

Will I have to participate in audits and inspections?

Yes, you will prepare for and support internal and external site audits and inspections, leading reviews and following up on action plans.

Is teamwork important in this role?

Yes, ensuring effective and proactive flow of information between stakeholders and collaborating with suppliers and departments is vital for this position.

What skills are essential for success in this role?

Advanced documentation skills, attention to detail, problem-solving abilities, and advanced knowledge of GMP practices are essential for success.

Is there an opportunity for professional development in this position?

Yes, there is an expectation to develop strong QA expertise, share knowledge, and provide training to new colleagues, enhancing professional development.

What is Hovione’s stance on inclusion and diversity?

Hovione values inclusion and diversity, fostering a work environment where differences are respected and all team members have the opportunity to achieve their full potential.

Hovione

In it for life

Manufacturing & Electronics

Industry

1001-5000

Employees

1959

Founded Year

Mission & Purpose

Hovione is an international company with over 60 years of experience in pharmaceutical development and manufacturing operations. As a Contract Development and Manufacturing Organization (CDMO) with a fully integrated offering of services for drug substances, drug product intermediates and drug products. The company has four FDA inspected sites in the USA, Portugal, Ireland and China and development laboratories in Lisbon, Portugal and New Jersey, USA. Hovione provides pharmaceutical customers services for the development and compliant manufacture of innovative drugs, including highly potent compounds, and customized product solutions across the entire drug life cycle. In the inhalation area, Hovione offers a complete range of services, from API, formulation development and devices. Hovione´s culture is based on innovation, quality and dependability. Hovione was the first Chemical/ Pharmaceutical Company to become a Certified B Corp, is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards.