Quality Assurance Manager

2 weeks ago

Singapore CSL Behring Full time

**Position Purpose**:
Reporting to the General Manager, Commercial Operations Asia, the Manager, Quality

Assurance Asia serves three primary functions:
1) The Site Quality Assurance and Compliance Representative for Singapore Operations,

2) The Local Quality Officer (LQO) for Asia Affiliate Operations,

3) A Global Affiliate Quality representative for global project and issue management.

The day-to-day support of the quality activities within the Asia Operations includes:

- Establish and maintain the CSL Behring Quality Management System. Ensure compliance with current local regulations and all CSL Behring global requirements for Asia Operations
- Final administrative release of all product batches for respective countries
- Provide oversight of the Quality Complaint process for the Asia Operations. Ensure Complaints are processed and closed according to established KPIs.
- Provide Quality Subject Matter Expert (SME) oversight in support of Warehousing & Logistics, and Customer Service (GDPs) activities.
- Manage deviations impacting the release and distribution of material and work to resolve issues in order to limit local and global market impact. Ensure that short and long-term corrective actions are effectively implemented.
- Serve as a real-time support and interface function for Asia Commercial Operations, Global Logistics, and all Sites of Manufacture.
- Ensure all relevant GxP activities are completed and documented in support of a new product launch in the Asia Operations, as applicable
- Fill the role of Affiliate Recall Coordinator for recalls or market actions impacting the Asia markets and additionally support counterfeit or suspect product investigations.
- Works with the CSL external supplier quality (ESQA) function to ensure Quality Agreements between the Asia Operations, 3rd Party Logistics providers, and authorized distributors are in place and/or updated as needed. In addition, ensure that the established audit program is implemented and executed in a timely manner.
- Create, review, and update Local and Global SOP Quality Procedures and Work Instructions as required
- Review and evaluates new or changing GMP/GDP Regulations and assesses local impact to current business practices for Asia Operations
- Drive continuous improvement and efficiency initiatives in Global and Local Quality operations of CSL Behring.
- Improve the Global Quality Management System by providing ideas and suggestions to the Quality Systems Operation Teams. Serve as a contact between Global Quality Affiliates and other Global Quality functions in issues related to product quality and compliance.

**Main Responsibilities and Accountabilities**:
1. Maintenance of the CSL Behring Quality Management System including documentation at the affiliate
- Act as Local Quality Officer (LQO) for the Singapore affiliate and where applicable other Asia markets
- Ensure that the global CSL Behring policies in the form of a local Quality Management System have been established and implemented for Asia Operations
- Create and maintain local SOPs/Policies according to the CSL Behring global policies and Asia regulatory requirementsCreate and maintain Quality Agreements as appropriate

2. Establish and maintain a GxP training program at the affiliate including appropriate documentation
- Coordination of changes to GxP processes, SOPs or other critical documentation
- Deviation and CAPA management

3. Provide oversight for product release and disposition decisions
- Assure compliance with local regulations and guidelines, internal policies and procedures, and external customer requirements at the affiliate level collating release documentation
- Liaison with manufacturing site QPs and batch release personnel
- Making a final decision on whether or not to release each batch of product in conjunction with his quality colleagues if necessary
- Making disposition decisions about product returns
- Provide final administrative release of all product batches in associated electronic systems
- Collaborates with Customer Service, Medical Information and Global Logistics Operations to promptly resolve customer inquiries relevant to product quality and possible temperature/storage concerns following release of product into the distribution network.

4. Serve as Recall Coordinator ensuring that the actions involved in recall actions are completed
- Management of recall and other field actions in accordance with local and global CSL Behring procedures

5. Manage receipt and processing of Product Technical Complaints (PTC)
- Processing, follow-up, investigation and reporting of product technical complaints from region according to global procedures

6. Ensuring compliance with all CSL Behring global SOPs, policies and quality system requirements as appropriate to the position including:

- Prompt reporting of all Adverse Events, Product Technical Complaints or Non-Conformities according to SOPs
- Completion of required training and maintenance of

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