Quality Assurance Compliance Manager

Purpose of position:
Maintaining and overseeing quality standards within Logistics department based on Internal standard such as ISO 9001, GSDP, GMP, GCP, and GDP MDD standards as well as to comply with Regional guideline & Principal requirements to cover all product types such as pharmaceutical products including clinical trial products & healthcare products, veterinary product, and medical device across all relevant work sites and locations.

Responsibilities:

1. Quality System Management at Logistics Department

• Ensuring that all quality-related documentation and record will be created, revised, maintained, used, and destroyed according to the requirement in ZP quality system management and/ or documented client requirement. follow up, review and verify Deviation and Change Control to ensure reports are issued with proper investigation and corrective / preventive actions.

• Coordinate and support external audits as conducted by local principal affiliates, international principal affiliates, certification bodies or internal audits.

• Coordinate and supervise to always concerned sections in monitoring compliance of operations to Standard Operating Procedures.

• Work closely with Quality System team for quality system, document update and quality record maintenance and ISO 9001 audit surveillance activities.

• Maintain quality system to comply with client's requirement, International standard, RQA guideline and local regulatory.

2. Quality Compliance (Process control)

• Process Control: Ensuring that the process control in all warehouses under Zuellig Pharma Thailand management, and External warehouse will comply with the ZP requirement and/ or documented client requirement that mutually agreed.

• Process Control: Ensuring that any activities relating with GxPs in Clinical Trail area, Logistics process of Pharmaceutical/ Consumer product, Animal Health product and Medical devices including Inbound area, Redressing area, Inventory, Outbound area, Cold chain area, Transportation, and Goods return will be complied with ZP requirement and/ or documented client requirement that mutually agreed.

• Process Control: Ensuring that the rejected product in particular if it is contaminated product is properly managed in order to prevent any harm to other products and employees.

• Batch Release for Commercials Product: Ensuring that the batch release process will be maintained and correctly performed in order to release the Commercials product that comply with the client requirement and regulatory requirement to the markets.

• Batch Release for Clinical trial material: Ensuring that the clinical trial material will be processed according to Depot Project Instruction and the correct process prior to deliver to the site and all documents are maintained.

• Quarantine Management: Ensuring that the quarantine management will be maintained and properly performed in order to maintain the segregation/ separation and prevent an inadvertent release.

• Computerize System Validation: Ensuring that the validation or periodic review of an existing computerize system is performed as the requirement.

3. Quality Assurance Business Partner of Clinical Trial Support Business unit

• Collaboration and alignment with business unit on the regulatory requirements, industry standards, client, and customer requirements

• Quality Assurance Support and Risk Management

• Quality Systems improvement

• Ensuring that related non-conformities is reported, recorded, investigated, and provide the proper corrective and preventive action to reduce/ improve the significant incident reoccurring.

4. Miscellaneous

• Improvement process to reduce the non-conformities

• Perform other tasks as assigned by VP - Quality

Minimum Qualifications:

• At least Bachelor's degree or Master's degree in Pharmacist/ Science/ Food Science or related fields
• At least 7 years direct experience in quality assurance of pharmaceutical product/ food product and approximately
• Have an experience in Qualification/ Validation of packaging/ equipment and/or facility
• Good knowledge or adequate training in Good Manufacturing Practices and/or Good Storage and Distribution Practices.
• Good interpersonal and organizational skills, team player with service-oriented attitude.
• Working knowledge of QA management principles, practices and procedures preferred, as well as experience with audit and regulatory systems.
• Good command of English and computer literacy.