Commercial Quality Associate Manager

3 weeks ago


Ho Chi Minh City, Vietnam Johnson & Johnson Full time

Johnson & Johnson (Vietnam) Ltd is looking for Commercial Quality Associate Manager located in Ho Chi Minh City, Vietnam. If you are looking for more than a job, and are inspired by the opportunity to create the future to bring quality of life to the world, we invite you to build your career with us.

**Overall purpose of job**:

- Lead as a Subject Matter Expert on Quality Management System for Pharm sector, this position is responsible for maintenance, compliance and improvement of the quality system in accordance with local regulations, J&J Policies and associated Pharm sector standards
- Responsible for releasing the imported products,
- Plans, coordinates, and directs quality assurance programs designed to ensure continuous production of products consistent with established standards by performing the following duties personally or through subordinates.

**Responsibilities**
- Lead as site SME for quality systems for Pharm sectors which including Change Control, NC/CAPA, purchasing control, product quality complaint, field actions/ recalland other quality systems as assigned. Provides guidance to all involved in enough documentation, impact assessment and investigation, monitors trends and implemented actions to ensure timely completion
- Perform monthly quality metrics report.
- Lead all quality activities relating to Pharmaceutical warehouse which including oversight on receiving, dispatching, handling of storage, temperature control, batch traceability, product releases, return, repack-relabeling
- Trains, plans, schedules and assigns work, appraises performance and resolves problems.
- Manage and drive the quality system to meet local regulation, applicable cGxP and corporate requirements.
- Ensure the quality and regulatory compliance of GxP activities.
- Ensure the local implementation of the JnJ quality processes effectively
- Supervise the daily activities in accordance with JnJ standards, organizations policies, and applicable laws.
- Responsible for quality Issue investigation and CAPA completion. Ensure all CAPA are properly executed by the relevant functions, external stakeholders in a timely manner.
- Manage audits (internal and/or external) by coordinating and communicating with relevant functions.
- Provide training in quality processes, updated or new procedures, standard to local team.
- Oversight the quality execution at local distributors and suppliers.
- Manage local suppliers and distributors through the process of selection, qualification, assessment, audit, monitoring of suppliers and distributors.
- Approves changes to documentation and processes.
- Performs other related as required
- Review and approve relabeling batch record, quality documents for product release, receiving, dispatching as assigned
- Manage controlled products

**Qualifications**:
**Job Requirement**:

- Pharmacist
- At least 5 years of experience in Quality Management in Pharmaceutical Companies
- Experience with GSP of Drugs or equivalent quality standard program preferred.
- Demonstrated ability on analytical and process oriented.
- Issue remediation experience.
- Good command in English.



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