Overview
Senior QA Executive/Pharma/ Jobs in Singapore, Singapore at People Profilers
Senior QA Executive (Pharma/1 year contract/$7200)
Job Description:
RESPONSIBILITIES Perform/support quality activities, resolve quality issues and investigation in RDC to support the continuous supply of commercial products in compliance with applicable local regulatory authority and the company’s global/release requirements. Provide support to ensure all relevant quality input/support from RDC for all relevant post market activities in responsible countries are executed timely as per applicable local regulatory authority and the company’s global requirements to minimize interruption to the supply of quality compliant products.
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 a timely manner. Provide support for the QA oversight/management for the development, implementation, and maintenance of a fit-for-
purpose
RDC QMS 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. Maintain all quality documentation such as product specifications, SOPs, in accordance with policies. Ensure that all product specifications and related documentation are in alignment with current registered details. Manage complaints, review complaints investigation, CAPA plan and effectiveness review, and monitor 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 authorities, 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 Bachelor’s 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 the 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. We regret that only shortlisted candidates will be notified.
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Title: Senior QA Executive/Pharma/
Company: People Profilers
Location: Singapore, Singapore
Category: Quality Assurance – QA/QC (Data Analyst), Healthcare (Data Scientist)
