Spécialiste, Systèmes d’Assurance Qualité

Choose Gender Male Female Prefer not to respond Current Location Current Organization Current Designation Functional Area Work Experience(in years) Total Work Experience - Months Were you referred by a Jubilant Employee Yes No Password Confirm Password Disclaimer : Jubilant Ingrevia Limited and Jubilant Pharmova Limited collect and use your personal information when you visit our careers webpage. Your personal information is processed in the HR Talent Acquisition system so that Jubilant"s teams can consider and manage your application for the advertised position and contact you. The information you provide to us during the application process may be shared for the purposes of Jubilant"s recruitment program with one or more of Jubilant"s subsidiaries globally. By clicking the "I Agree" checkbox below you are agreeing to your personal information being processed and used as outlined in our Privacy Policy. For a detailed description on how we process and keep safe your personal data, please see our Privacy Policy at: http://www.jubl.com/privacy-policy. You have the right to withdraw your consent or to object to the further processing of your personal information at any time. Further, if you would like to review, correct or update your Personal Information, you can do the same by accessing your profile on our career portal.To delete Personal Information that you have previously provided to us, e-mail us at privacyofficer@jubl.com. I Agree JOB DESCRIPTION - Clients Qualifications : Formation : Specialist, Quality Assurance Systems Jubilant HollisterStier, a subsidiary of Jubilant Pharma Holdings Inc., is currently recruiting a Specialist, Quality Assurance Systems to join our team What do we offer? A culture that values growth and professional development opportunities, a highly competitive base salary, comprehensive medical, dental, and disability insurance programs, a group retirement plan, as well as health and wellness programs. Jubilant HollisterStier is a rapidly growing company with offices in Kirkland, Quebec, and Spokane, Washington. As a fully integrated contract manufacturing organization, Jubilant HollisterStier has the capability to manufacture sterile injectable formulations, as well as solid and semi-solid dosage forms. Our four facilities in North America and India provide specialized manufacturing services for the pharmaceutical and biopharmaceutical sectors. Jubilant HollisterStier proudly belongs to the Jubilant Pharma family. For more information, visit www.jublhs.com . We will continue, with the greatest care for the environment and society, to create value for our customers and stakeholders by offering innovative products and cost-effective solutions through growth, profitability, and prudent resource investment. If you're ready for a rewarding challenge, we invite you to take the first step and apply today Jubilant Pharma Holdings Inc. and all our subsidiaries are proud of the diversity of our workforce. Our goal is to have a workforce as diverse as the patients and clients we serve. We have an inclusive environment where our employees can thrive, and where our differences are welcomed. By embracing our differences, we create products that benefit our patients, clients, and human health in general. Position Objective Coordinates and supports quality-based systems in order to optimize Jubilant’ processes and ensures appropriate technical content and compliance to GMP regulations, Jubilant’ standards and customers’ requirements. Key Accountabilities Responsibilities: Specialist, Quality Assurance Systems (APQR sub-function): - Annual product review: (APR) Gathers and compiles data, and provides to customer as per established timeline. - Ensures integrity and traceability of all data generated and reported. Notifies immediately Manager of any out-of-specification, out-of-trend, incomplete information and other irregularities. - Leads quality based initiatives at both documentation and process level in order to optimize Jubilant’s operations and programs. Ensures ongoing improvement of established procedures and adherence to new systems/processes and compliance with regulatory requirements. - Performs additional duties as assigned by Management. Specialist, Quality Assurance Systems (CC sub-function): - Change control management: Coordinates change controls to determine impacts on products and/or processes. - Leads quality based initiatives at both documentation and process level in order to optimize Jubilant’s operations and programs. Ensures ongoing improvement of established procedures and adherence to new systems/processes and compliance with regulatory requirements. - Performs additional duties as assigned by the Manager, Quality Systems Department. - Performs any other tasks assigned by Management. Specialist, Quality Assurance Systems (SOPs and documentation sub-function): - Administers, coordinates, or executes the following activities and documentation. - Evaluate and approve change controls related to SOP’s. - Format and issue SOP’s. - Load documents in SAP for approval purposes (SOP’s) - Distribute controlled copies of SOP’s and ensure that all obsolete copies are destroyed. - Maintains database of controlled paper copies of SOP’s - Notification and follow-up for SOP review - Master documentation control of SOPs such as issuing or cancelling documents according to tasks in notifications. - Issue production batch records for manufacturing, packaging and inspection. - Print production batch records for manufacturing, packaging and inspection. - Print Stability labels according to SOP if required - Print Sampling Plan and corresponding labels according to instructions. - Verification and Confirmation of the PI Sheet in SAP - Print identification labels for production if applicable Specialist Quality Assurance Systems (Specifications sub-fonction): - Prepares, reviews and maintains specifications for finished products, raw materials and packaging components in SAP ensuring technical accuracy and compliance to customers’ requirements, GMP, and compendia standards, and adherence to established timelines. - I ssues and maintains analytical methods, and/or analytical work orders. - Provides technical support and guidance relative to the TSE/BSE and other regulatory contaminants requirements - Translates applicable regulatory requirements as well as customers’ requirements into technical documentation and ensures internal communication of these to appropriate departments - Performs additional duties as assigned by Management. Key Interfaces External Interfaces - Clients Internal Interfaces - Operations, Quality, Production, Commercial, Validation, Technical Services, Supply Chain Education Qualification: - BSc in chemistry, microbiology or closely related discipline. Experience Required: - Minimum five (5) year experience working in Quality Assurance/control or regulatory compliance within pharmaceutical or healthcare industry. Skills Required: - Knowledge with compendia (USP, EP, and BP) and cGMP regulations. - General knowledge of Quality systems, Operations and Quality control processes. - Proficiency in computer and data entry (Microsoft Office, TrackWise, MasterControl and SAP environment). - Bilingual (French & English). Proficiency in English is essential. #J-18808-Ljbffr