GENERAL SUMMARY OF POSITION Assist Associate Director to: Lead Plant QA Department
and manage the QMS (Quality
Management System) and product regulatory
compliance related activities. Manage the product
inspection/ testing activities to ensure customer quality requirements and
relevant international standards are met. Assist in the definition
of Company goals and objectives and, subsequently, to assist in control QA
budgets to ensure achievement of Company financial plans whilst meeting
customer and regulatory/legislative requirements. Ensuring compliance with
the entire local, corporate and external regulatory bodies and quality
requirements.
RESPONSIBILITIES & SPECIFIC ACCOUNTABILITIES
1. Quality Management Systems:
- Maintenance of Management Systems ISO9001
- Report the Quality
System effectiveness to Top Management and
Management Team
and make recommendation for improvements.
- Ensure the
promotion of awareness of Quality Management System, regulatory and
customers’ requirements throughout the Ansell plant.
- Support Plant
Manager and Head of QA on organize and conduct the scheduled QMS Management
Review Meeting.
- Analysis the quality level
(Process Average / First Pass Yield / Rolled Throughput Yield / Rejects / Functional properties of gloves) and finding root
causes for any variations/defects and propose
corrective and preventive actions as appropriate
- Coordinate/Carry out internal quality audits to
ensure conformance to QMS requirements in accordance with Audit Program/Plan.
- Be the liaison person and Quality Management
Representative for external audits.
2. Regulatory Affairs:
- Ensure legislative
compliance, standards, customer requirements and other requirements
related with products and Management Systems.
- Liaise with Artwork Team for approval status in order to ensure compliance.
3. Control of Non-conforming Products:
- Ensure effective control of non-conforming
product.
- Communicate the disposition of NC products as
authorized by Head of Quality.
4. Corrective Action Preventive Action (CAPA) system:
- Drive timely and effective CAPA resolution.
- Issuing Non-Conformance Material Reports (NCMRs) whenever necessary due to failure and ensuring effective Corrective Actions implementation.
5. Standard Operational Procedures:
- Maintain the Quality Management System Documentation
System.
- Ensure compliance of Global Standard Operational
Procedures.
6. Quality Records and metrics:
- Manage the quality records storage and
retention system.
- Maintain Quality metrics for internal and external reporting. Perform
trend analysis as required.
- Provides analysis of Internal and External Quality issues
and provide recommendations for improvements
7. Providing Technical Support to Manufacturing:
- Provide technical and quality advice related to
trouble shooting of new, existing manufacturing or quality problem.
- Provide technical and quality advice related to
new raw material evaluation and implementation and procedural changes.
- Provide technical and quality advice related to
process and product improvement.
- Assist in Product failure and complaint investigation and
identification.
- Risk analysis activities whenever necessary.
8. Incoming, In-process and Final Release Product
Inspection and Certification:
- Manage and maintain effectiveness of Incoming,
In-process & Final Release Inspection activities for Ansell.
- Authorize finished product releases and approve
on product conformance certificates.
9. Validations:
- Support to manage the function of process and
raw material change validation of the company.
- Support in new product validation and design
& development.
10. Customer Complaint:
- Handling Customer Complaint
- Lead and ensure effective customer complaints
handling and resolution.
11. Supplier Quality Management:
- Provide support in Suppliers selection and
qualification
- Assist in the process of supplier / vendor
evaluation and ensure compliance with the Quality System
12. Change Control Management:
- Head of Change Review Board
- Ensure effectiveness of Change Control
Management
13. Laboratory Testing and Calibration:
- Administer the Laboratory testing/inspection
activities which include incoming materials, in-process
solutions/compounds/product, finished product, boiler water and effluent
testing as well as environmental control.
- Provide necessary support in inter-plant product
testing and benchmarking program.
- Administer the Calibration Program of the
company concerning testing/inspection and relevant measuring and process
control equipment.
- Perform and oversee inspection and testing of
products to determine conformance to established product specification
and standards,
14.
Provide problem-solving
support using statistical and analytical techniques. Ability to use
Statistical Process Control (SPC) tools appropriately to improve process
capability.
15.
Be an expert in
compounding preparation; develop standard operational procedures, train operators.
Support shift leader in this area.
16.
Be an expert in
“Process Controlling of glove manufacturing” and guide / lead and train the
process/machine technicians.
17.
Others:
- Participate in and
support continuous improvement initiatives.
- Support implementation
efforts of Six Sigma, Lean in the Plant.
- Carry out assigned
responsibilities related to Safety and Health.
- Any other duties as
assigned by the QA Head and/or General Director.
KEY POSITION REQUIREMENTS
Education
- Higher education -
university with three to five years of quality/chemical industry related
experience.
- Experience in QA or related manufacturing environment.
- Certified/Qualified Lead Auditor – Quality Management System.
- Familiar with the Regulatory requirements for various types of
gloves.
- Extensive experience in handling external quality audits and
internal audits.
- Experience in Customer Relation Management.
- Good command of the English Language. Strong written and verbal
communication skills.
Job Experience
- Supplier Quality management experience preferred.
- Process and product validation experience preferred.
- Experience in diagnosing, troubleshooting, and problem solving.
- 3 years and over of experience in the
position of Quality Manager in production.
Knowledge and Skills
- Excellent knowledge in the field of chemistry
- Be an expert in compounding preparation, develop standard
operational procedures, train operators
- Statistical Process Control expert and Statistical knowledge
- Ability to write accurate, precise report and present data
clearly in English.
- Ability to evaluating the testing data against established
specification
- Work professionally with highly confidential information
- Ability to communicate effectively with sourcing partners’
relevant functional team and global stake holders in English
- Ability to manage multi tasks with enthusiasm and prioritize
workload with attention to details
- Flexibility with respect to work assignments in support quality
audits, new learning, and travel
- Good working
knowledge of computer database systems, Microsoft applications, and
various software programs
- Good interpersonal and organizational skills
- Ability to communicate across all levels internally/ externally
and across geographies
- Good analytical skills and attention to details
- Good drive for results and commercial access
- Team player
- Highly motivated and able to work independently. Excellent
leadership
Условия:
- Totally "White" salary, payment twice per month. Discussed with a successful candidate
- Bonus system, additional motivation payments
- International company with human policies. Location in Uzlovaya (Plastik territory)
- Additional medical insurance