Quality Assurance Specialist

Hovione•East Windsor, NJ

About The Position

Join a Market Leader Hovione is an independent family owned international group of companies. From the beginning, we have set ourselves above and apart through our innovative technological and productive capabilities, reaching a top spot in the world market as an integrated Contract Development and Manufacturing Company dedicated to helping Pharmaceutical Customers bring new and off-patent drugs to market. Our people are the main asset for our continued success. Reaching over 1950 team members, from 36 different nationalities, that are located across Asia, Europe and North America (Portugal, US, Macao, Ireland, China, Hong Kong, Japan, India, and Switzerland), including 4 production sites. Working at Hovione means reaching for innovation and excellence in everything we do: for our clients, our partners and, above all, our patients. That is why we are In it for life. You will be responsible to: 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.

Requirements

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)
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

Nice To Haves

Experience of working with Regulatory Affairs and a basic knowledge of the function (desirable)

Responsibilities

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
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
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.
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.