QA / QC Specialist (Pharmaceutical/ Medical Sector, Office hours 5 days)

Recruit Express Pte Ltd| Date Posted: 1-Jul-2019
EA Licence No: 99C4599|EA Personal Registration No: R1551708
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Job Nature:
Permanent, Contract
Position Level:
Experienced, Manager
Qualification:
Diploma, Bachelor's / Honours

Job Description

QA:

  • 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

QC:

  • 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

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
  • 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)


Thank You.

Leon Leong De Cong
R1551708

Recruit Express (Healthcare & Lifesciences Division)
EA License: 99C4599

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