QA / QC Specialist (Pharmaceutical/ Medical Sector, Office hours 5 days)
- 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
- Perform analyses and tests of drug products, raw materials, in-process materials, release test samples or stability samples, packaging materials, quantitative assays on samples, and/or finished products from manufacturing, to ensure quality standards and compliance with established specifications
- Perform a variety of qualitative tests or qualitative assays on samples using techniques that vary from standard analytical equipment to modern and automated instrumentation.
- Utilize electronic laboratory information systems for acquisition and processing of analytical data
- Responsible for the accurate, timely and compliant execution of assigned projects, analytical testing and related documentation
- Ability to write technical documents (i.e. protocols, reports, change controls, SOPs)
- Advanced knowledge of analytical chemistry, chromatography (HPLC/UHPLC) and drug dissolution testing
- Serve as a mentor for more junior analysts within the team providing guidance and direction as needed
- Broader understanding of other aspects of the business and apply quality principles when reviewing documentation and making decisions/ suggestions
- Stays current on new requirements & making associated recommendations that affect area of expertise. Qualifications Education and Experience Required:
- Thorough knowledge and understanding of USP, cGMP, ICH and HSA guidelines
- Use of risk assessment tools within own area using knowledge, managing risk and assessing impact to make decisions
- Promote Quality and GMP by analyzing the implications of deviations, and implement solutions under guidance. Continuous Improvement:
- Provide feedback on systems and processes to promote continuous improvement and champion selected changes
- Grow in the job, accountable for establishing and accomplishing annual personal development goals Communication:
- Participate in daily direction setting huddles to provide feedback and ensure alignment on daily/weekly/monthly objectives
- Actively participate in regular one-on-one meetings with direct supervisor Problem Solving:
- Troubleshoot problems encountered with methods and instruments - routinely solve, choosing among clearly defined alternatives
- Ability to independently solve more complex problems – takes new perspective using existing solutions
- Applies root cause problem solving principles for identification and implementation of effective corrective and preventive actions
- 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
- Location : West
If you are interested in any of the positions, do kindly drop your most updated resume to [Click Here to Email Your Resume] (Attn: QA/ QC Specialist- Leon)
Leon Leong De Cong
Recruit Express (Healthcare & Lifesciences Division)
EA License: 99C4599
Recruit Express Pte Ltd