Senior Customer Logistic Service Quality Control Specialist Vietnam and Philippines

Reporting to: Senior Manager, CLS Q&C, OneSEA
Functional group: CLS Q&C APAC

** Overall purpose of job:
The Q&C CLS Specialist is responsible for the oversight and execution of Quality Management Systems and compliance at Vietnam/Philippines Distribution Centers (3PL) & Philippines’s distributor plus

The Q&C CLS Specialist serves a single point of contact to CLS Quality in Vietnam/Philippines 3PL Distribution Centre & Philippines Distributor Plus Quality related matters and liaise with multiple Quality organizations to drive timely resolution of Quality related issues.

The Q&C CLS Specialist identifies opportunities to continuously improve quality, cost and time factors, consistent with both Sector and CLS business objectives. Identifies significant business issues, prioritize for action, and lead improvement opportunities and problem solutions.

The Q&C CLS Specialist with her/his supervisor plans, coordinates, and directs quality assurance programs designed to ensure effective and consistent processes with established standards by performing the following duties personally or through subordinates.

** Essential duties and responsibilities:
Distribution and Inventory Management Processes
- Responsible for Quality in product receiving process, product identification and product traceability together with 3PL DC team.
- Responsible for ensuring compliant to the product destruction process
- Responsible for ensuring that 3PL DC is oversighting any of Quarantine/hold/stop-ship/recall processes within the 3PL DC
- Responsible for ensuring DC is compliant with the product return procedures
- Ensuring all Vietnam/Philippines’s DC (#PL/Distributor Plus under scope of CLS meets all appropriate related requirement such as: regulatory authority, and sector requirements.
- Support and maintain regional Q&C CLS Dashboard as per agreed target
- Implement and support Quality System implementation within the scope of CLS, includes ensuring Vietnam/Philippines’s sites meet CLS DC QSCAN, GWP requirements and conducting internal audit to JNJ TPL as well as ensure satisfactory closure of JJRC AAP of JNJ 3PL.
- Support CIP program related to CLS Q&C
- Ensure compliance to the Global and Regional Guidelines and Policies including enterprise standards related to Quality and Regulatory Compliance for CLS.
- Established quality agreement at all Vietnam/Philippines’s 3PL for warehousing, transportation and other 3rd party services related.
- Ensure timely JNJ DC quality reviews are conducted and actively participate on management review of site business quality
- Support an appropriate and timely closure of related to quality and compliance customer complaint at JNJ warehouse and 3PL Vietnam/Philippines
- Responsible for ensuring that DC is following the agreed quality agreement on managing their QMS such as Management of CAPA process, records and document management, validation, implementation, and changes of Cal/PM, CAPA, NC, IA, Doc mgmt. software systems oversight, change control
- Partners with CLS Operations to implement business solutions and leads compliance efforts associated with complex projects and activities through effective implementation of the Audit Action Plan (AAP) process
- Supplier Audit program and ensure inspection readiness and provide strategic focus for quality and compliance by working with appropriate functional areas to identify continuous improvement opportunities
- Coordinates and reports timely and accurate metrics and analysis per J&J policies. Reporting responsibilities within Vietnam/Philippines include (but are not limited to): Metric evaluation and reporting in CURVE entry updates.
- Accountable for Quality management of repacking, relabeling, over labeling, kitting, and reworking operations conducted within the DC
- Accountable for accurate and timely communication of temperature control excursions occurring within the DC to appropriate partner
- Accountable for the investigation of temperature control excursions and subsequent remediation activities

** Special requirements:
1. 3 to 5 years experiences in QC or QA Function of any Consumer, Medical devices or Pharmaceuticals Industry
2. Bachelor Degree in Science (Life Sciences, Pharmaceutical, Microbiology, etc) or Engineering required.
3. Good knowledge of Good Distribution Practices (GDP), GMP and validation- demonstrated knowledge and application of QSR, ISO9001, ISO13485 and other international standards.
4. Certified Auditor of GMP, ISO 9001, or ISO 13845 (will be plus point)
5. Knowledge of manufacturing environment or repackaging/relabeling environment
6. Fluency in English language required.

Job Requirements
Essential knowledge and skills:
1. Good knowledge of Good Distribution Practices (GDP), GMP and validation- demonstrated knowledge and application of QSR, ISO9001, ISO13485 and other international standards.
2. Certified Auditor of GMP, ISO 9001, or ISO 13845 (will be plus point)
3. Knowledge of manufacturing environment or repackaging/relabeling environment
4. Fluency in English language required.
5. Demonstrated knowledge and experience in quality or operations function.
6. Task oriented with proven experience in the delivery high quality work
7. Proficiency in Microsoft Office (PowerPoint) another tools required to develop training materials
8. Excellent analyzing / decision making ability
Core competencies required for this role:
1. Strong communication skills
2. Strong work ethic, integrity and respect
3. Customer (internal and external) driven approach
4. Exercises Good Judgment and Drives Change in continuous changed Regulatory environment

- Under company's policy

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