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Senior Manager/Associate Director, Quality Assurance

Company: Novelstar Pharmaceuticals Inc.
Location: Cranbury
Posted on: August 7, 2022

Job Description:

Senior Manager/Associate Director, -Quality Assurance -Locations: Cranbury, NJFunctions: Quality Assurance and ComplianceJob descriptionNovelstar Pharmaceuticals Inc. (A Fosun Pharma Company) is hiring Senior Manager/Associate Director, Quality Assurance, located in Cranbury, NJ. If you are looking for a great pioneer opportunity to develop your career, be empowered to take charge of your future at Novelstar.Novelstar Pharmaceuticals, Inc. is a Fosun Pharma (Fosun Pharmaceutical (Group) Co., Ltd) company. Our mission is to develop novel pharmaceutical drug products (NDA), deliver high quality generic products (ANDA) and provide service to pharmaceutical industry. Our vision is to be a robust growth innovation leader and partner in global healthcare to enhance people`s lives.The Senior Manager/Associate Director, -Quality Assurance will participate in and conduct daily activities in accordance with Quality Operations and Systems processes to support several Novelstar Pharmaceuticals areas such as Manufacturing, Warehouse, Laboratory, between others. -The position will be responsible for the lifecycle management and maintenance of Quality documentation such as, but not limited to: Standard Operating Procedures (SOP), Training Records, Logbooks, Master Batch Records, Investigations, Change Control, CAPAs, Vendors, Metrics, Protocols, -Reports, Quality Agreements, Equipment Qualification and/or Validation Documentation. Will actively participate in collecting data, building databases, and developing technology solutions to support the Quality Systems organization. In addition, will participate in executing Quality Operations functions to support R&D formulation, GMP Laboratory, cGMP manufacturing and packaging processes. Key Responsibilities include but are not limited to: --- - - - - - - - -Develop and implement Quality Management systems to ensure that all products manufactured, packaged, tested, and released in compliance with cGMPs and FDA regulations. --- - - - - - - - -Prepares the site for regulatory inspections, and host regulatory inspections and customer audits. --- - - - - - - - -Responsible for Quality oversight of manufacturing operations and ensure operations are in compliance cGMP and Regulatory requirements, while maintaining an efficient workflow to facilitate the operational excellence. --- - - - - - - - -Responsible to establish systems, policies, procedures in accordance with the cGMP requirements, (e.g., batch records, SOPs, validation protocols, and reports). --- - - - - - - - -Ensure proper review and approval of batch manufacturing record and packaging batch record, Protocols, Reports, process evaluation reports and process validation reports. --- - - - - - - - -Responsible for review and approve of equipment qualification protocols, and oversight equipment qualification activities with respect to 21 CFR requirements and user privilege access. --- - - - - - - - -Ensure all Deviations, Investigations, OOS, and OOT's are properly investigated and provides final approval for all investigations. --- - - - - - - - -Quality decisions regarding quality for all batches and products, including batches under investigations. --- - - - - - - - -Ensure the proper training/ development & evaluation of all site personnel. --- - - - - - - - -Monitor and report quality key performance indicators identifying and leading opportunity for improvements to achieve and maintain high quality standards and ensure customer satisfaction. --- - - - - - - - -Oversees all hiring decisions and ensures staff is appropriately trained. Takes necessary disciplinary action for any issues affecting employee performance. --- - - - - - - - -Support the maintenance and administrating all quality documentation, these documents must be organized, filed/achieve, and inventory for easy access and retrieval within the Documentation designated area. Considered the custodiam of all GMP records. --- - - - - - - - -Assist in the issuance of effective SOP and distribution of related documentation to the support areas to assure the effective version is always available. --- - - - - - - - -Responsible for all the training program to assure -all employees have their trainings up to date against each training matrix and assure compliance. --- - - - - - - - -Responsible for the management and compliance of all plant-wise Logbooks, this task includes the creation, issuance and filing of return logbooks. --- - - - - - - - -Assist in authoring SOPs and/or other quality documents such as protocol, reports, between other. --- - - - - - - - -Responsible for the assignment of document equipment identification numbers, as applicable. --- - - - - - - - -Assist in the preparation of quality reports, using different tools such as power-point pentation's and/or excel, as required. --- - - - - - - - -Inspection, documentation, and management of GMP retain samples. --- - - - - - - - -Assist in the routing for approval different quality documents, such as SOP, Change Controls, Investigations, and/or Corrective Actions, as required. In addition, assists in the monitoring of open document records timelines (e.g., track open records) up to closure. --- - - - - - - - -Responsible for the plant equipment PM/Calibration database, the data base will include the equipment PM/Calibration frequency and requires periodic reviews to assure compliance from the functional areas. --- - - - - - - - -Acts as the incoming quality person to receive and sample GMP material for analysis and inspection process. --- - - - - - - - -Review and approve GMP material for pilot/pivotal for BE/PK batch manufacturing. --- - - - - - - - -Issuance of approve manufacturing/packaging records for the manufacturing of pilot/pivot drug products for BE/PK studies. --- - - - - - - - -Assist in the review and approval of executed manufacturing records to ensure that the documents, raw materials, in process products and final products are compliance to cGMP requirements. --- - - - - - - - -Assist in the release process -of -pilot drug products for BE/PK studies. --- - - - - - - - -Facilitates and/or participates in any required meetings related to quality, as assigned. --- - - - - - - - -Complies with all company policies standards and procedures. --- - - - - - - - -Other duties assign by the supervisor.Qualifications and Requirement - --- - - - - - - - -A bachelor's degree required. Degree concentration in a scientific, engineering, or related pharmaceutical area is preferred. --- - - - - - - - -Minimum of 8 -years' experience working in a regulated quality environment (Pharmaceutical Industry preferred) within the Quality, Laboratory and/or Manufacturing areas. focusing on R&D, GMP Lab and pilot plan, technology transfer, commercial manufacturing, and NDA/ANDA submissions, GMP training. --- - - - - - - - -Ability to take initiative and work independently while effectively managing timelines required. --- - - - - - - - -Maintain cooperative working relationships with internal and external partners required. --- - - - - - - - -Ability to perform in fast paced environment and in stressful situations is required. --- - - - - - - - -Demonstrate ability for self-motivated with inherent can-do attitude. --- - - - - - - - -Additional domestic travel and internal travel as required -5%. --- - - - - - - - -Fluent in English (written and verbal).Knowledge and Skills - --- - - - - - - - -Experience in current Good Manufacturing Practices (cGMP) pertaining to pharmaceutical. --- - - - - - - - -Inspections Management Skills - Knowledge of regulatory audits (FDA) and collaborate with all department management for successful completion of facility audits. --- - - - - - - - -Regulatory Knowledge - FDA regulatory requirements / guidelines in order to implement regulatory requirements and ensure compliance. --- - - - - - - - -Experience leading and conducting CGMP audits (vendor audits, contract testing laboratory) and pre-approval inspections of pharmaceutical production and packaging facilities. --- - - - - - - - -Good -knowledge in computers, such as Office Tools (Microsoft Office, Excel, PowerPoint). --- - - - - - - - -Excellent organizational skills and proven experience working in a fast-paced environment. --- - - - - - - - -Possesses strong organizational, people skills /teamwork and detail oriented. --- - - - - - - - -Excellent verbal and written communication skills and positive attitude. --- - - - - - - - -Excellent computers skills (Microsoft Words, Excel, PowerPoint etc.). --- - - - - - - - -Ability to manage multiple priorities and projects concurrently. --- - - - - - - - -Problem solving skills and result oriented. Functions: Quality Assurance and Compliance

Keywords: Novelstar Pharmaceuticals Inc., Hicksville , Senior Manager/Associate Director, Quality Assurance, Professions , Cranbury, New York

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