Location: Ireland Cork City
Closing Date: 27 Oct 16
Type: Full Time
Salary (£): On Application
Reporting to the Head of Engineering/Site MS&T Head, this person will; own the process knowledge of the product(s) assigned throughout the commercial lifecycle, maintain the oversight on process capability, through data trending and statistical analysis of critical parameters, ensuring process(es) are robust, in continued state of validation and continuously improving. ...
Reporting to the Head of Engineering/Site MS&T Head, this person will; own the process knowledge of the product(s) assigned throughout the commercial lifecycle, maintain the oversight on process capability, through data trending and statistical analysis of critical parameters, ensuring process(es) are robust, in continued state of validation and continuously improving. Ensures seamless flow of knowledge and information across functions, and with other sites when applicable, with focus on the product(s). Provides second line technical/scientific process support. To manage and direct the Product Engineering group. The chief responsibility of the group is to lead projects in Technology Transfer, Automation, Metrology, and site to site NPI.
1. Technical Oversight & Knowledge
• Provide technical leadership for all technology transfers into the Alcon Ireland facility per CORKSOP000201/ QM5.1.
• Provide technical leadership to optical metrology activities at Alcon Ireland and work with FTW R&D on the introduction of new technology optical metrology
• Provide technical leadership to Automation projects at Alcon Ireland. Ensure projects are resourced with experienced engineers to ensure success.
• Ensure manufacturing process equipment is correctly sourced, installed and maintained in compliance with all regulatory/procedural requirements. Provide project leadership for equipment innovation and upgrade projects.
• Maintain the oversight of the process of the product(s) assigned ‘door to door’ at the Site (e.g. from raw materials to primary packaging).
• Maintain the knowledge and the history of the product(s) process throughout the entire commercial lifecycle, since transfer from development to date.
• Provide the necessary data for the technical activities involved in transferring out a product, focusing on existing knowledge, through the appropriate documentation and supporting at the receiving site as needed.
• Initiate and support investigations and improvement projects (quality, efficiency), based on the above data analysis, involving cross-functional teams.
2. Compliance/Audit Support/HSE:
• Compliance with regulatory/corporate requirements. Continuously improve metrics in this regard for staff and areas of responsibility.
• Maintain their work in inspection readiness level and to provide the necessary support in any internal or external audit.
• Annual Product Review/Product Quality Review (APR/PQR): Review the PQR data and provide the correct level of discussion on it.
• Participate and/or lead (case by case) the change controls to its products and related processes.
• Ensure alignment of (regulatory) timelines for technical changes, transfers or launch, major deviations.
• Ensure continual Quality System compliance by adherence to established and evolving Alcon and Novartis QS requirements.
• Identification of future budgetary requirements (including major capital equipment and upgrades), preparation of equipment section annual budgets and ensuring the department operates within budget
• Manage department within targeted budget, projections, attendance, turnover and other goals as established
• Address exceptions from standards of performance and conduct by taking corrective action in accordance with company policy and procedure.
• Promote cooperation and teamwork with all departments by open, candid communication and timely coordination
• Own the Training Curriculum for its Job Profile and provides the necessary training and support to new associates joining this position.
• Provide all necessary information to perform the validation documentation, align with stability expert and QC labs to organize the stability samples.
• Supports Validation Lead and Experts to assess need and plan validations / re-validations / verifications, consulting approving and reviewing the process validation master plan, together with the Validation Lead or Validation Experts.
• Approves both Validation Protocols and Report
• Ensure that technical batches generate sufficient process knowledge by thoroughly testing critical variables and use the output to verify critical process parameters.
6. Single point of contact to Franchise Product Steward
• Liaise with Franchise Product Steward at divisional level and locally with functions (QA, Regulatory, Manufacturing, Process Support Lead Production associates with focus to ensure and improve product process capability. Additionally, keep process knowledge up to and maintain the product in constant state of validation.
• Create and maintain a product specific Quality Risk Analysis (QRAs).
7. Continued Process Verification (CPV), data trending and statistical analysis:
• Track CPV parameters from production, QC, control systems, etc. Monitor all critical variables and key variables as appropriate for the assigned product(s) (Critical Process Parameters CPP, In Process Control IPC parameters, Quality Attributes, Characteristics of raw materials. etc.) using statistical analysis and conducting regular product specific data trending.
• Utilize data trending and statistical analysis to:
• Deepen and broaden process understanding and knowledge.
• Detect issues in process capability, such as systematic quality defects.
• Identify trends of process deviations (e.g. deviation with common root cause).
• Assist initiating the product-specific monitoring of all critical In Process Controls (IPC) and release parameters in each laboratory (transfer of the product-specific Quality Risk Analysis).
• Ensure data and trending is visible and communicated at shop floor level. Minimum requirements • Knowledge of FDA regulations and other international compliance standards.
• Strong technical knowledge of processes used in IOL manufacture e.g. machining, Injection Molding, IOL metrology.
• Strong technical knowledge of IOL product and appreciation of impact of proposed process changes on product in role as Product Steward
• Ability to supervise, mentor and motivate a staff of highly technical people over three shifts.
• Ability to plan and to adapt to changing priorities.
• Excellent organization and communication skills.
• Must be capable of organizing and directing technical projects, planning, scheduling, allocating resources and multi-tasking.
• Ability to understand and interpret financial reports.
Minimum: Bachelor degree in Engineering/Physics or related technical discipline
Preferred: Desirable Desired: MSc or PhD in a related technical or business management discipline
Minimum: 10 years industrial experience in a regulated Medical Device/Pharmaceutical environment, including 5 years in a Supervisory/Management role
Preferred: >10 years industrial experience, >5 years middle/senior management experience
Novartis Pharmaceuticals UK Limited
Frimley Business Park
|Tel:||+44 (0)1276 692255|
|Fax:||+44 (0)1276 692508|
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