Co-ordinates and maintains the site Change Control process to ensure that this key element of the Quality Management System continuously operates in a compliant manner while meeting ongoing business requirements. The role may also involve supporting other quality system elements such as Deviations, CAPA or QRM as required. Essential Duties and Responsibilities: * Responsible for ensuring compliance with all aspects of Quality for the Raheen site inclusive of manufacturing, quality systems, quality control, validation, facilities, and materials management. * Primarily responsible for administration and oversight of the Change Control process but may also be responsible for one or more of the site quality systems including but not limited to; * Deviations * CAPA * Quality Risk Management * Responsible for review and approval of associated change control documents, and other documents such as: * Failure investigations * corrective/preventative action documents * Standard operating procedures * Maintaining the electronic systems used for Change Control, Deviation Management and CAPA. * Reviews procedures, policies and other instructional documents relating to quality systems to ensure compliance with company policy and local and international regulatory requirements * Provision of monitoring and trending metrics associated with change control and other site quality systems * Actively participate in continuous improvement initiatives. * Participates in regulatory and customer audits. * Participates in quality risk assessments. * Collaborates with functional departments to resolve issues and maintain compliance * Identify gaps in systems and develop feasible plans for correction * Training of personnel on change control and other quality system processes Education and Experience: * Requires BSc/BEng in scientific discipline or related field with 3+ years of relevant work experience in pharmaceutical or related industry. * This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about our Clients unwavering commitment to combining good science & good business.
Performs activities in support of dispositioning product while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Clients Standard Requirement Documents. Responsibilities * Represent Quality Assurance both internal and External, with Partners and Contract Manufacturers in support of complex Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution * Train and/or mentor junior employees, including providing insights and education on processes and procedures. * Provides consultation or advice in alignment with QA policies; and develop an understanding of external partner and manufacturers site procedures. * Perform activities associated with reading product records for disposition (e.g. manufacturing record review, receipt, inspection, document review, shipping, etc). Activities may be on site at a partner or contract manufacturer or at a desk * Review, edit, or approve Clients controlled documents * Review and approval of investigations associated with raw materials, product, laboratory, facilities, and materials. * Continually evaluating Clients processes and procedures with an eye toward continuous improvement Requirements * Requires BS/BA in scientific discipline or related field and minimum 2-year relevant experience. Relevant experience may be substituted for education requirement. * Understanding of aseptic filling and/or packaging operations is preferred. * Good organizational skills and attention to detail * Requires good written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally and cross-organizationally. * Ability to handle multiple assignments and changing priorities. * Ability to learn and utilize computerized systems for daily performance of tasks * Ability to prioritize, manage multiple tasks, and meet deadlines * Ability to work a varied schedule including off shift and weekends. * Ability to travel up to 25% of time.
Manages the QC Microbiology team and provides critical microbiology support to manufacturing and facilities. Essential Duties and Responsibilities: * Manage a team of laboratory analysts within the QC microbiology department involved in the analysis of raw materials, intermediates (in process) and bulk drug substance in a cGMP regulatory environment. * Implement and manage the environmental monitoring programme, including surface, settling and viable and non-viable particulate air monitoring of aseptic operations and controlled areas * Responsible for all QC microbiological aspects of cGMP compliance and sample analysis. * Design and oversee microbiological validations as needed for drug substance, in-process controls and buffers. * Manage the design, validation and execution of the clean utilities qualification and re-qualification program. * Support manufacturing personnel in the identification of microbiological root cause analysis and provide technical advice on QC related topics as needed. * Participate in the investigation and review of alert and action limit investigations as needed and implements corrective action as appropriate. * Ensure that all work carried out is in compliance with the required regulatory standards, conforms to company policies and standard operating procedures (SOPs). * Review and approve method protocols, reports and SOPs. * Assist in the preparation for internal/customer/regulatory inspections. * Ensure a safe working environment within the laboratory. * Proactively identify and implement lab process improvements, lean initiatives. * Oversee or conduct laboratory investigations and generates reports in response to invalid assays, Deviations, OOS/OOT. * Ensure that CAPAs and Change Controls are initiated and completed on time and in accordance with site procedures. * Present analytical data reports clearly and concisely to senior management, including QC performance metrics and trends. * Ability to train, develop and mentor direct reports and effectively manage the performance of individuals. * May be required to work shift. Education and Experience: * BS/BA in Microbiology or closely related field with 6+ years' experience in microbiology lab, preferably in the pharmaceutical or biotech industry with 3+ years' experience in a leadership role in microbiology laboratory management. * This is an opportunity to join a team select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more our clients unwavering commitment to combining good science & good business.
Responsible for leading instructional design within Technical Training, managing the eLearning program, training delivery standards, incorporating emerging learning techniques and technologies into the global training program. Essential Duties and Responsibilities: * Establish and develop instructional design standards, development models and socialise best practices across the organisation * Oversee Technical Training content within the learning management system, ensure content development is managed and completed to support overall training needs to departments. * Manage a team of Technical Training personnel responsible for eLearning content development. * Development and implementation of evaluation strategies to determine effectiveness of training. * Provide guidance to individual managers and employees to conduct training needs analysis to identify learning requirements by role and task. * Seek out and integrate novel learning technologies & training methodologies * Review and develop SOPs and other associated documentation pertinent for the training system. * Organize, facilitate and present training sessions to groups or individuals. * Coordinate and work in conjunction with the Management Team who oversee Technical Training. * Participate in evaluating and leading project implementations. * Assist in providing an employee, manager or regulatory agency the necessary information on training documentation or for regulatory inspections. * Participate in multidisciplinary project teams to coordinate and establish training goals Education and Experience: * Bachelors degree in related field and 6+ years relevant experience in the pharmaceutical or related industry * Preferred Experience considerations: * Experience in a GMP environment * Experience with HTML and web development (e.g. HTML 5, CSS, and Java Script) * Experience with e-Learning software (e.g. Articulate Storyline, Captivate, Adobe Creative Suite) * 3D modeling and animation experience