Hovione is an international company with over 55 years experience in the development and compliant manufacture of Active Pharmaceutical Ingredients and Drug Product Intermediates. With four FDA inspected sites in Portugal, the U.S., Ireland and China, Hovione offers integrated API, particle design, formulation development and GMP manufacturing. In the inhalation area, Hovione is the only independent company offering such a broad range of services.
Hovione New Jersey is expanding and we are looking for strong professionals to joni us and are currently recruiting for the following position.
The Quality Assurance Specialist promotes high quality standards and a continuous improvement culture within the operational areas at the New Jersey site in order to ensure that these are aligned with applicable quality regulations and the company s high quality standards. This role provides guidance and support to the project team in Quality Assurance (QA) related activities, assists the Head of Quality in achieving the department objectives, and manages the cGMP programs (e.g. validation, qualification, stability, environmental control).
Signs off the Certificate of Analysis and authorizes the release for sale of finished products.
Reviews and Quality Approves IOPs and process related documentation.
Approves change control documents and the respective implementation plan.
Approves qualification/validation documentation.
Authorizes rework and reprocess orders.
Identifies deficiencies of the Quality System and pro-actively suggests/requests improvements.
Prepares SOPs, department IOPs, quality related reports and change control documents (PdAs), when appropriate.
Approves process master documentation, product specifications and associated documentation.
Final product release: Reviews completed batch records and associated deviations.
Periodic follow-up of ongoing deviations and PdAs to assure timely closure of documentation.
Responsible for evaluation/approval of equipment cleaning.
Approves equipment qualification protocols and reports.
Approves process validation protocols and reports.
Manages site stability program including approval of stability data report.
Handles client's quality related issues.
Provides support during Client audits / Inspections.
Periodic follow-up of client audits action plans and client complaints.
Actively communicates with the various areas to identify areas for improvement.
Conducts regular inspections of the operational areas to verify compliance with cGMPs (e.g Internal Audits).
Provides cGMP training to staff.
A minimum of a BSc in Chemistry/Science or Chemical Engineering, with a minimum of 3 years of industrial experience working under cGMPs.
Hands-on experience in writing and reviewing documentation for process, operations and validation.
Possess an in-depth understanding of the cGMP requirements for the various areas (Process, Operations, Quality Control, ICH guidelines).
Competent in the application of cGMP principles to process, equipment, and facility
Results driven, team player, able to deal with multiple projects/tasks
Available, autonomous and able to take ownership
Exciting full time opportunity in a growing Company, using continuous manufacturing technology under a Quality by Design approach in an innovative setting.
Competitive salary and benefits commensurate with the job function and candidate s relevant experience.
Great work environment, with a strong focus on quality and execution of top class science in state of the art equipment.