Description
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
- 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
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)
- 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
In compliance with the New Jersey Pay Transparency Act, Hovione discloses a base pay range for this U.S. based position. Actual pay is influenced by location, skills, experience, and qualifications. Non-exempt employees are eligible for overtime, and all roles may include a short-term incentive bonus. Employment is at-will, and compensation may change based on performance or market conditions. Benefits include 401(k), paid time off, leaves, and health coverage (medical, dental, vision), subject to plan terms. Full benefit details are shared upon offer.
Quality Assurance Specialist Compensation Range: $92,040 to $147,264 annually
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.
Notice to Agencies and Search Firms Representatives
Hovione does not accept unsolicited resumes from agencies or search firms for this job posting. Any resumes submitted to Hovione by a third-party agency or search firm without a valid written and signed search agreement will become the sole property of Hovione. No fees will be paid if a candidate is hired for this position as a result of an unsolicited referral. Thank you for your understanding.
