Quality Assurance Executive

2 weeks ago

Changi, Singapore Bollore Logistics Asia Pacific Full time

**About the role**

The incumbent will be part of a larger team within the Logistics department in providing seamless and customer-focused solutions to support the achievement of business objectives.

**What you will be doing**

**QMS Maintenance and Administration**
- Ensure proper administration of QMS for the facility in accordance to the procedure
- Maintain up to date master lists and proper control of all released QMS documents
- Process owner of Quality-related SOPs and conduct regular reviews in accordance to procedure
- Collaborate with Operations to ensure proper review of operational SOPs and continuing compliance with all applicable regulatory requirements e.g. PIC/S GMP guide and customers’ quality requirements
- Review and approve all work-related materials for display on the Healthcare site
- Ensure handling of pharmaceutical products adheres to QMS and IATA requirements.

**QMS Training and Development**
- Prepare and administer relevant SOP, Quality and GMP refresher training for Healthcare Hub staff
- Ensure that training records for all staff in the Healthcare Hub are maintained and up to date
- Ensure appropriate administration and execution of structured training programme for all work functions in collaboration with Operations

**Supplier Assessment**
- Assess new suppliers according to the procedure

**Equipment/System Qualification, Calibration and Maintenance**
- Ensure proper management of equipment/system qualification and validation according to the relevant requirement
- Ensure that the environmental monitoring, pest control, cleaning, and equipment maintenance are performed and documented as per requirement and procedure
- Conduct quality review to ensure equipment calibrations/preventive maintenance are done per the stipulated frequency in the procedure

**Internal Audits** (Self-Inspection)**
- Lead, plan and perform periodic internal audits in accordance to the relevant procedure
- Prepare and submit report to the Head of Department for review and approval

**Deviation, Complaints and C/PA Management**
- Designated person to handle deviation, product complaints, product recall and return, in collaboration with Operations, ensuring that investigations and C/PAs are implemented and closed out appropriately

**Batch Release**
- Authorized person to perform Batch Release for repackaged medicinal products according to the procedure and ensuring that all relevant regulatory and GMP requirements are complied with.

**Product Quality Review**
- Designated person to perform product quality review according to the procedure

**Requirements**:

- Diploma/Degree in Science or related field
- Minimum 1 year of Quality working experience
- Proficient in MS Office
- Good team player with good communication and interpersonal skill
- Ability to multi-task and work independently

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