Primary activities include, but are not limited to:
· Processing of customer complaints received against finished products including handling of returned customer complaint samples.
· Perform Adverse Event investigations and support compilation and analysis of PQC and AE data for Complaint Unit business processes.
· Support Market Action activities including BPDR/FAR submission, Fact Finding, and Recall
· Authoring Annual Product Reviews (APRs).
· Authoring and managing Quality Agreements (QAs) concerning both other Merck Sites and external vendors and/or contractors involved in the GMP aspects of the Site.
· Providing Quality oversight of supplier information across all categories of suppliers that service WP.
· Run queries / reports / metrics in support of business processes
· Update Standard Operating Procedures (SOPs) related to these business processes as needed.
· Participate/support compliance projects to sustain and/or enhance compliance
· Participate/support projects to enhance efficiency and effectiveness
· Support ad-hoc data requests and analysis
· Author, review, and approve procedures and other control documents.
· Assist with aspects of Regulatory Inspections and commitments
· Participate in internal audits and shop floor inspections
· Performing gap analysis and remediation
· Quality Support/ownership for applicable automation systems
· Regulatory surveillance
· Conduct training on compliance topics
· Execute projects as required by the Associate Director
Requirements:
- Min Diploma / Degree in Chemical Process Technology, Foodscience, Biotechlonogy, Biology, Biomedical Sciences, Science or its equivalents
- No Experience Needed, Full training/ on the job guidance will be provided
- Able to start immediately
If you are interested in any of the positions, do kindly drop your most updated resume to [email protected] (Attn: QA Specialist)
Thank You.
Leon Leong De Cong
R1551708
Recruit Express Pte Ltd (Healthcare & Lifesciences Division)
EA License: 99C4599
