Johnson & Johnson Careers
Assistant Manager, Quality Engineering
Requisition ID: 1905734843W
- Support, consult, train and lead quality improvement projects in SLH, including process design, packaging, repack relabel, temperature control and continuous improvement projects.
- Utilize Quality Engineering tools and techniques to establish sampling plans, develop quality plans, conduct and participate in FMEA activities, support reliability engineering activities, conduct process and systems audits and to assist in specification development.
- Analyzes routine and test data looking for improvement opportunities.
- Designs and implements experiments (DOE's) for process and product improvement and validation testing.
- Provides statistical support for sampling plan and analysis, DOEs, Paretos, ANOVA, and SPC applications.
- Evaluate distribution quality performance capability and develop criteria to monitor and improve existing processes.
- Provide SME support for design and execution of all validations including but not limited to – CSV, Equipment qualification, Facility qualification, Lane qualification, Temperature Control Standard requirements etc.
Duties and Responsibilities:
- Responsible for quality oversight for validation of controlled ambient pack-out & transportation lanes changes.
- Responsible for Quality management of pack-out process.
- Initiate and execute validation studies throughout the facility.
- Interact with all levels of management and staff to manage and facilitate the validation process from inception to completion by enlisting cooperation, support and approval for identified validation projects.
- Plan, schedule and organize validation projects for new and existing areas, including labelling processes, plant systems, and equipment.
- Provide support for projects as required.
- Identify necessary internal and external resources for completion of validation projects and secure the necessary support from all stake holders.
- Interface extensively with the all stake holders, Operations and other departments to identify projects and problems requiring validation support.
- Plan and assign priorities to ensure critical projects meet required deadlines.
- Develop and implement all necessary Standard Operating Procedures for validation of facility, processes, equipment qualification, computer system validation. Lead for the planning and execution of IQ/OQ/PQ and validation campaigns as well as review the protocols for process validation, equipment qualification and computer system validation to ensure compliance as per J&J standards and applicable regulatory requirements.
- Coordinate validation and IQ/OQ/PQ activities with all stake holders including outside contractors providing leadership, training and guidance.
- Monitor and support the execution of the protocols through training, facilitating and problem solving activities.
- Review and analyze data generated from validation activities.
- Write validation final reports that present, summarize and offer conclusions on the validity of the process based on the results of the analysis as required. Coordinate the facility qualification program by providing support for preparing the protocols, monitoring the execution, auditing the results and assisting production in resolving any identified problems.
- Recommend validation strategies, priorities and resources.
- Ensure accuracy and integrity of protocols, reports and documentation generated to meet J&J and applicable regulatory requirements.
Quality Management Systems
- Responsible for design and execution of validation strategy including but not limited to – CSV, Equipment qualification, Facility qualification, Lane qualification, Warehouse Management Systems etc.
- Responsible for participating in Internal Quality audits, audits of transportation suppliers and 3PLs associated with the DC.
Distribution Supplier Quality Management
- Provide support for the Qualification of distribution, logistics, transportation, and material suppliers.
- Responsible for carrying out managerial responsibilities in accordance with the organization's policies and applicable laws; including training employees; planning, assigning, and directing work; addressing complaints; and, resolving problems.
Site Specific Responsibilities
- Responsible for day to day activities of SLH.
- Preparation / Review and Approval of validation documents
- A Master/ Bachelor’s degree (B.S.) in engineering, science, mathematics or statistics is required.
- A minimum of 6 - 10 years related experience and/or training; or equivalent combination of education and experience is required. Experience in medical device industry is preferred.
- Demonstrated knowledge and experience in quality, validation &/ operations function.
- Task oriented with proven experience in the delivery high quality work.
- Fluency in English language required.
- Strong communication skills.
- Strong work ethic, integrity and respect.
- Proficiency in Microsoft Office (PowerPoint) another tools required to develop training materials.
- Excellent analyzing / decision making ability.
- Customer (internal and external) driven approach.
- Knowledge of Good Distribution Practices (GDP), GxP, Warehousing and Processing Systems, GAMP, ISPE, Qualification and Validation.
- Demonstrated knowledge and application of QSR, IS09001, IS013485, applicable regulatory requirements and other international standards.
- Knowledge of warehousing environment.
Johnson & Johnson Pte. Ltd. (8435)