RESPONSIBILITIES
- Perform/support quality activities, resolve quality issues and investigation in RDC to support the continuous supply of commercial products in these countries in compliance to applicable local regulatory authority and the companys global/release requirements.
- Provide support to ensure all relevant quality input/support from RDC are provided for all relevant post market activities in responsible countries are executed timely as per applicable local regulatory authority and the companys global requirements to minimize interruption to supply of quality compliant product
- Provide support to ensure all relevant quality input/support to business projects, new product introduction, product launches and product variation in responsible countries are provided in timely order
- Provide support for the QA oversight/management for the development, implementation, and maintenance of a fit for purpose RDC QMS as per applicable to support RDC operations for the Asia region and/or country quality operation/activities.
- Ensure that RDC local operations, internal procedures and systems in use are in full compliance with the QMS, standards and policies, GDP, and regulatory requirements.
- Ensure SOPs, QMS management principles are adhered to, review impact assessments and implement any updates to QMS Policies, manage QA Objectives and KPIs.
- Maintains all quality documentation such as product specifications, SOPs, in accordance to policies.
- Ensures that all product specifications and related documentation are in alignment with current registered details.
- Complaints Management, Review complaints investigation, CAPA plan and effectiveness review. Monitoring of complaints trends.
- Support the QMR for the RDC (primary labeling/secondary packaging, redressing, warehousing and distribution) and prepare the facility for GMP inspection and certifications by local and various other countries' health authority, host and prepare/complete CAPA for inspection findings and close inspection.
- Management and continuous improvement of Quality Management System (QMS)
- Any Ad Hoc activities as specified by the Reporting Manager
REQUIREMENTS
- Bachelors in Science or engineering discipline or a Diploma with extensive experience in cGMP, or able to show a high level of competency or equivalent level of knowledge
- 5 relevant years of experience in quality assurance and operations in pharmaceutical / medical devices industry with at least 3 to 5 years experience in GMP manufacturing and 2 to 3 years in Commercial Quality (GDP) environment and/or RDC operations.
- Must have knowledge of regulatory standards related to GMP, GDP, RDC PIC/S, ICH, ISO 13485 and cold chain management.
- Experience in Audit, QA Batch Management, experience in Regional Distribution Centre (RDC) QA operations, Complaints management, Deviation Management, Change Control Management, CAPA/RCA (Root Cause Analysis) Management and Recall Management.
- MNC, 5 days week
- 1 year renewable contract with full benefits (21 days annual leave, medical + completion bonus)
All Successful candidates can expect a very competitive remuneration package and a comprehensive range of benefits.
Kindly email your resume in a detailed Word/pdf format to [email protected]
We regret that only shortlisted candidates will be notified
People Profilers Pte Ltd
Tel: 6950 9753
EA Registration Number: R1111375
EA licence number 02C4944
EA Personnel: Lee Hui En Ashley
