Senior Quality Assurance Specialist - Hightstown, United States - Hovione

Description

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.

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.

We are looking to recruit a Candidate:

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.

Hovione is a proud Equal Opportunity Employer

Inclusion and diversity are key to us. At Hovione, that means a work environment where differences are valued, and everyone is treated with fairness and respect.

We want all our team members worldwide to feel supported, respected, and have the opportunity to achieve their full potential, regardless of their age, gender, religion, disability, sexual orientation or ethnicity.

(https:
//en-careers-\_iframe=1&hashed=


Hiring Request Post Information* :
Posted Date3 weeks ago(2024/4/10 19:00)


ID
of Openings1Job LocationsUS-NJ-East Windsor

Job FamilyQUALITY
#J-18808-Ljbffr