Responsibilities
- Provides support to commercial operations in Asia Pacific to releasing in-bound shipment from the manufacturing sites to the markets.
- Ensure that appropriate standard of Good Distribution Practice (GDP) in relation to the transportation of products, including environmental parameters are monitored in accordance with the requirements of EU directive and regulations of the markets supplied.
- QA operations. Establish and maintain documentation to support the Quality Management System (QMS) for company (local and international). Remain abreast with the QMS relevant to the operation at company. Assist the preparation and review of Quality Technical Agreement (QTA) and coordinate with other parties as assigned by Quality Director.
- Ensure that valid licenses from suppliers, warehouse and distributors are received and maintained. Download and review temperature records of each shipment (or obtain download records from warehouse/distributor).
- Release in-bound shipments as per the criteria agreed with suppliers.
- Co-ordinate with CMO-contact or Supply team for the case of documentation errors or temperature excursion or other incidents that may impact product quality/safety during transit.
- Carry out duties in compliance with QMS and CMO (Contract Manufacturing Operation) management
- Create, update and maintain SAP database in relation to quality areas.
- Ensure timely and effective escalation of quality incidents to Quality Director.
- Maintain HSA licenses and responsible for Singapore's HSA audits. Support GDP's regulatory audits in SEA upon receiving request. Audit new distributors and renewal audits as per schedule. Manages and oversees the audit schedule, working with regional audit team to ensure that suppliers and contract manufacturers have been audited
Requirements
- Bachelor's Degree in Pharmaceutical Science or able to demonstrate equivalent level of knowledge.
- Quality experience within the industry, and application of Quality Systems
- Experience of working with cross-site and multi-functional teams
- Strong interpersonal skills
- High sense of urgency and service mind
- Excellent oral and written communication skills
- Problem identification and solving skills
- Resilient and adapt to different working cultures
- Able to commit to business travel if required
- Job Reference: QWR36RW9
All Successful candidates can expect a very competitive remuneration package and a comprehensive range of benefits.
Kindly email your resume in a detailed Word format to [email protected]
We regret that only shortlisted candidates will be notified
People Profilers Pte Ltd
Tel: 6950 9754
EA Registration Number: R22110899
EA License number: 02C4944
EA Personnel: Celeste Wong Xin Yann
