Through innovation, strategic acquisition and an ability to quickly meet market developments and emerging technologies, CIBA VISION® has grown from a start–up to a company that sold more than 1.9 billion lenses in 2009 to address the eye care needs of the patients we serve. Our products not only improve patients' vision, they also enhance self-esteem, appearance and well-being, and ultimately make their lives better by allowing for freedom of vision and superior comfort to match today's active lifestyles and demands.
At the heart of our business is a relentless desire to make a difference in people's lives by improving, protecting and preserving eyesight. This commitment, which requires exceptionally high quality standards and cutting-edge innovation, is best expressed in the CIBA VISION® mission statement, "Shared Passion for Healthy Vision and Better Life." Our mission guides our 5,900 employees and our customers to deliver the dream of healthy vision and better lives today and in the future.
With worlwide headquarters in Atlanta, Ciba Vision is a global leader in the research, development and manufacturing of optical and ophthalmic products and services, including contact lenses and lens care products. Ciba Vision products are available in more than 70 countries worlwide.
We invite suitable candidates to apply for the following position :
Compliance Manager
Work locations Riau - BatamClosing Date: 27-8-11
Responsibilities:
* Manage and facilitate the Quality Management System implementation, standardization and adherence within CIBA VISION Batam manufacturing in accordance to cGMPs, legal, ISO, regulatory requirements as well as CIBA and Novartis Quality Manual requirements.
* Develop, implement and maintain batch record review and release process, annual product review, quality management review, CAPA, non-conformance management and local complaint processes for CIBA VISION Batam manufacturing.
* Provide follow-up to all non-conformances, ensuring development of actions plan to address issues preventing reoccurrence. This is inclusive of an effectiveness verification process following implementation of corrective and preventative actions.
* Develop, implement and maintain the internal audit program. Perform internal audits per an established schedule ensuring all quality systems are checked on an annual basis.
* Develop, implement and maintain the supplier audit program. This includes the coordination and/or performance of external audits. The position could include a minimum of 10% travel.
* Assist in hosting Regulatory inspections. Responsible for ensuring all observations are appropriately addressed and compliance review initiated.
* Review audit readiness strategy and oversee preparedness for regulatory bodies inspections by managing field CAPA’s, any regulatory actions, follow-ups and assisting in product problem resolution.
* Responsible for Quality metrics and establishment of follow-up actions as required in ensuring metrics are maintain within appropriate parameters.
* Responsible for the improvement process associated with the quality systems to ensure review on a periodic basis continually increasing compliance as well as staying current or ahead of industry trends.
* Responsible for staying aware of the FDA database and website with respect to industry changes, challenges and regulatory trends.
* Responsible for the review of validation and process changes in manufacturing to ensure compliance with standards and submissions.
* Responsible for the GMP and technical training programs to ensure they incorporate the required modules to sustain compliance.
* Responsible for ensuring data integrity is maintained through routine audits of quality systems.
* Provide leadership, direction and support to the people within QA departments and ensure they are qualified, achieve a high level of competence, are motivated and carry out their duties in a safe and effective manner.
* Work with the Quality staff to ensure quality plans are being maintained.
Requirements:
* Bachelor in Engineering or Physical Sciences/Chemistry/Physics or its equivalent.
* 5 to 7 years Quality Management experience in pharmaceutical/medical device/health care environment.
* Experience in Quality Control, Quality Assurance and Compliance or Regulatory Affairs.
* Knowledge in change control, statistical process control, training systems and manufacturing process.
* Proven knowledge in cGMPs/Regulatory Affairs/Validation/Laboratory, 21CFR820 and ISO 13485 requirements.
* Excellent oral and written communication skills.
Process Engineer - Automation & Process Controls
Work locations Riau - BatamClosing Date: 27-8-11
Responsibilities:
* Provide technical support for manufacturing operations including troubleshooting, investigating and resolving automation issues.
* Analyze all issues related to automation and control, develop optimal solutions and lead implementation to improve existing level of automation for reliability and output.
* Responsible for technical support and continuous improvement of automation systems in various developmental projects and in manufacturing.
* Responsible for developing various automation projects, scope, schedule, cost, implementation plan and user requirement specifications with input from all stake holders and to ensure design meets the Quality and other business requirements (DQ).
Requirements:
* Bachelor in Engineering/Mechatronics/Electrical/Mechanical or Computer Engineering or its equivalent.
* Minimum 3 years hands-on experience with electro-mechanical troubleshooting in a high-volume automated manufacturing environment, covers PC based controlled machines, instrumentation, vision system, control & automation at the design and implementation level. Proven experience in PLC programming, such as Allen Bradley, Modicon, Keyence, GE Fanuc, Siemens, Mitsubishi, Omron, etc.
* Able to program and configure HMI or SCADA of any of the following software packages from Wonderware, Rockwell Automation, Siemens, etc.
* Must be able to create and read logic and flow diagrams for program design, programming, simulation and testing, and start-up.
* Experience using CAD softwares such as AutoCAD, Solidworks, Pro E, etc.
* Setting up servo drive systems (Allen Bradley, Yaskawa, etc) experience.
* Ability to develop and implement standard engineering practices, as well as provide detailed documentation upon project completion.
* Excellent English Language Proficiency.
Process Engineer - Color Specialist
Work locations Riau - BatamClosing Date: 27-8-11
Responsibilities:
* Establish and maintain an efficient production process and system.
* Provide process improvement & re-engineering for product yield & quality improvement.
* Provide technical specifications necessary to control the production process.
* Investigate the process and quality failure and provide solution to correct them.
* Carry out the change request and evaluate the change affects on validation process.
* Manage and execute engineering study protocol which includes data collection and analysis.
* Support process, equipment and technology transfer & implementation.
* Provide or facilitate technical training for the relevant personnel.
* Support other department on major technical trouble-shooting.
Requirements:
* Bachelor in Engineering or its equivalent.
* 5 years working experience in manufacturing plant, preferably in pharmaceutical/medical device.
* Knowledge in industrial equipment, process controls and troubleshooting.
* Ability to develop and implement standard engineering practices, as well as provide detailed documentation upon project completion.
* Good project management.
* Excellent oral and written communication skills
Supplier Quality Engineer
Work locations Riau - BatamClosing Date: 27-8-11
Responsibilities:
* Develop, implement and maintain the supplier audit program. Ensure that supplier audits are conducted as per an established schedule.
* Assist in supplier audit and follow through the audit report and response from supplier or users.
* Responsible for ensuring all suppliers are categorized as per global SOPs.
* Responsible for conducting periodic supplier performance monitoring as per schedule and plan.
* Responsible for supplier management training programs for staff.
* Responsible for ensuring Data Integrity is maintained through routine audits of quality systems.
Requirements:
* Bachelor in Engineering or Physical Sciences/Chemistry/Physics or its equivalent.
* 3 to 5 years Quality Management experience in pharmaceutical/medical device/health care environment.
* Experience in Quality Control, Quality Assurance and Compliance or Regulatory Affairs.
* Knowledge in change control, statistical process control, training systems and manufacturing process.
* Proven knowledge in cGMPs/Regulatory Affairs/Validation/Laboratory, 21CFR820 and ISO13485 requirements.
* Excellent oral and written communication skills.
Water System Engineer
Work locations Riau - BatamClosing Date: 27-8-11
Responsibilities:
* To manage Solution Systems in compliance to site Quality System and Production demand.
* To plan and manage the operation of entire Water Solution System in the plant.
* To lead in troubleshooting and to response promptly to any machine downtime in Water Solution System.
* To upkeep the integrity of the system by implementing and adhering to all company policies and HSE practices.
* To support production line in terms of supplying Purified Water, Water Solution and Waste Water System ensuring quick response times.
* Design and write engineering study protocol and execute the protocols which include data collection, analysis and provide recommendation if further improvement is required.
* To ensure good quality results according to the Key Performance Indicators (KPIs) set by the management.
* To check and approve all daily/weekly reports and update changes in SOPs. Ensure all documentation and filling are well managed.
* Responsible for budget planning and controlling, purchase of spare parts and control the section expenses.
* To instill new technology innovations, motivation, manufacturing efficiency and quality. Provide leadership, guidance and strength to subordinates.
* To implement Good Manufacturing Practices (GMP), Good Document Practices (GDP), ISO 9000 standards and FDA regulations.
* Practice in cost reductions, cost savings and environmental projects. To lead a team and champion at least one major project (six months duration).
* To ensure solutions equipments are in top performance by ensuring proper systems operation, preventive maintenance and solution system health checks.
Requirements:
* Bachelor Science/ Engineering in Chemical or Mechanical
* 2 years working experience as a Utility, HSE leader in manufacturing plant, preferably in pharmaceutical/medical device.
* Experience in DI water, UPW, Waste Water treatment would be advantageous.
* Good exposure in technical field, Good Manufacturing Practice (GMP), Good Document Practice (GDP), Quality Management System.
* Understand pharmaceutical water system requirement. Excellent command of English language, self motivated and self-starter.
* Good problem solving and decision making skills. Well verse in Microsoft Applications
* Has management and interpersonal communication skills. Knowledgeable with pharmaceutical water systems and it’s guidelines. Good troubleshooting skills and project management.
Planning Superintendent
Work locations Riau - BatamClosing Date: 27-8-11
Responsibilities:
* Lead Material & Production Planner, including plan and follow up on material availability, execute production input based on agreed plan by HQ and CV-Batam Planning Management, monitor and follow up priority to make sure delivers best service to Customers. Work closely with internal Department to achieve company KPIs.
* Ensure adequate capacity to support periodic builds on an ongoing basis.
* Ensure there are adequate raw materials to support the daily/ weekly plan
* Monitor and ensure Production is running as per production plan
* Monitor and expedite critical SKU’s to minimize potential back orders and past due MOs.
* Ensure adequate MO’s from Global Supply Planning to support production plan and timely issuance of MO’s.
* Ensure accurate data entry of manual sales order, dispatch the order timely and correctly and response to customer inquiry
* Provide accurate reports and timely dispatch to relevant parties
Requirements:
* Degree in Industrial Engineering, Sciences, Mathematics or related fields.
* Minimum 5 years experience in Production Planning, Logistics or Inventory Control.
* SAP experience, English, Microsoft Excel and Power Point proficient.
* This job is need analytical skill, negotiation skill, organize capability and well communication with all level.
Planning Supervisor / Team Leader
Work locations Riau - BatamClosing Date: 27-8-11
Requirements:
* Degree in any discipline education background
* Minimum 2 year’s hands-on experience in similar position with exposure in MNC environment
* Must be computer literate
* Must be able to speak and write reasonably good English
Production Supervisor
Work locations Riau - BatamClosing Date: 27-8-11
Requirements:
* Degree in Industrial/ Electronic/ Electrical/ Mechanical any discipline
* Minimum 3 year's experience in a similar position with exposure in MNC environment
* Must be computer literate and strong people managing skill
* Able to work on shift and long hours
* Must be able to speak and write reasonable good English
Formulation Laboratory Technician
Work locations BatamClosing Date: 27-8-11
Requirements:
* Diploma (D3) in Chemistry/ Chemical Engineering or its equivalent
* Minimum 1 - 2 year’s experience in similar position with exposure in MNC environment
* Familiar with statistical tools application and Microsoft Office
* Possess analytical skill and understand English
* Able to work on shift and long hours
* Fresh graduate are welcome
Please email your resume to:
hr.recruit@cibavision.com
Or Apply Link
