Clinigen

Quality Officer

Posted: 17 hours ago

Job Description

As a Quality Officer, you will:Support the Quality Specialists and Quality Manager in maintaining GMP and GDP standards across operationsHelp manage the Quality Management System (QMS), including change controls, non-conformances, CAPAs, and risk managementAssist with client and regulatory audits, including coordination and follow-up on observationsPrepare reports, conduct data analysis, and support process improvements across business areasCommunicate quality requirements to employees and provide training on QMS procedures when neededInvestigate quality issues, customer complaints, and supplier concerns, identifying root causes and supporting corrective actionsContribute to document control by creating, reviewing, and maintaining SOPs, work instructions, and quality recordsCollaborate with third-party suppliers, customers, and internal teams to resolve quality-related mattersSupport additional quality activities such as product complaints, recalls, batch release checks, artwork approvals, and discrepancy handlingProvide general administrative and operational support to the wider Quality teamAdditional DutiesPlease note that this list is not exhaustive. As part of a dynamic business, tasks and responsibilities may vary, and flexibility is expected. Additional duties may include:Supporting quality complaints (product and service) and recallsAssisting Quality Operations in the GMP warehouse, including batch release, artwork proofing and approvals, discrepancy handling, and temperature excursion managementRequirementsA Diploma/Degree in Life Sciences, Pharmacy/Pharmacology, or Chemistry (preferred)Experience in a Quality Assurance role or related field; audit hosting/support experience is an advantageKnowledge of GMP and GDP guidelines for medicinal productsUnderstanding of WDA(H), MS, and MIA(IMP) license conditions (desirable)Strong communication skills with the ability to work independently and as part of a teamHigh level of self-motivation, accountability, and disciplineExcellent IT, planning, administrative, and organizational skillsA solutions-oriented mindset with strong problem-solving abilityFlexibility to adapt to changing priorities and act with urgency when requiredExceptional attention to detailBenefitsIn return for your valuable contributions and commitment to our organization, we are pleased to offer you an attractive and comprehensive benefits package that includes:A competitive monthly salary that reflects your experience, skills, and the industry standards, ensuring that you are fairly compensated for your hard work and dedicationA performance bonus designed to reward exceptional performance and achievements, providing you with additional financial incentives as you excel in your roleGenerous annual leave of 20 days, allowing you the opportunity to take time off for rest, relaxation, and personal pursuits, promoting a healthy work-life balanceOngoing professional development opportunities, including training programs, workshops, and access to resources that will help you enhance your skills and advance your career within our organization

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