Description<\/p>\n
\tFine Chemicals Corporation requires the services of QA Compliance Inspectors for our Quality Assurance Department.<\/p>\n
Requirements
\nOverview<\/p>\n
\tResponsible for ensuring that all manufacturing activities at the facility comply with current Good Manufacturing Practices (cGMP), regulatory requirements, and internal quality standards.
\n\tTo provide oversight of batch documentation, batch release, audit readiness, OTIF (On-Time In-Full) support, and plant floor compliance monitoring.
\n\tCollaborate with production, QC, and engineering teams to ensure GMP compliance and product quality.
\n\tPromote a culture of quality and compliance across operations.<\/p>\n
Responsibilities<\/p>\n
\tReview and approve Batch Production Records (BPRs), cleaning logs, and associated documentation.
\n\tEnsure completeness, accuracy, and compliance of batch records with regulatory and internal standards.
\n\tEvaluate and close deviations, CAPAs, and change controls related to batch production.
\n\tMake informed decisions on batch release, ensuring product quality and regulatory compliance.
\n\tCompile, maintain and drive traceable and auditable batch release documentation.
\n\tCollaborate with the relevant operational teams to support timely batch release.
\n\tPrioritize QA activities to align with production schedules and delivery commitments.
\n\tIdentify and mitigate quality-related risks that could impact OTIF performance.
\n\tMonitor and report on QA-related OTIF metrics and drive continuous improvement initiatives
\n\tTrain new staff members on SOPs in transition period (including GMP induction).
\n\tPerform GMP training to support adherence to the GMP training schedule.
\n\tIdentify refresher or awareness training needs across the site.
\n\tPrepare for and support internal audits, regulatory inspections (e.g., SAHPRA, FDA, etc.), and customer audits.
\n\tTrack and close audit findings and ensure timely implementation of corrective actions.
\n\tMaintain audit readiness across all departments.
\n\tMonitor manufacturing operations to ensure compliance with cGMP, GxP, and internal SOPs.
\n\tConduct routine inspections and compliance walkthroughs on the production floor.
\n\tProvide real-time QA support during critical manufacturing and cleaning operations.
\n\tEnsure plant floor activities align with quality and safety standards.
\n\tRisk assessment participation, review and approval.
\n\tSupport IQ\/OQ\/PQ activities pertaining to validation.
\n\tReview and approve cross contamination assessments.
\n\tPerform, review and approve line clearance authorizations.
\n\tSupport the implementation and maintenance of the site\u2019s Quality Management System (QMS).
\n\tParticipate in investigations of non-conformances and implement corrective and preventive actions.
\n\tIndependently assess deviations and non-conformances and make timely quality decisions.
\n\tEnsure data integrity and compliance with ALCOA+ principles across all quality records.
\n\tAssist in the development and revision of SOPs, work instructions, and training materials.
\n\tWrite, review and approve technical reports related to deviations, CAPAs, and change controls<\/p>\n
Skills Required<\/p>\n
Background\/Experience<\/p>\n
\tMinimum a tertiary qualification \u2013 bachelor\u2019s degree in pharmacy, Chemistry, Microbiology, Biochemistry, or Chemical Engineering (NQF Level 7 or 8).
\n\tGMP and QMS experience \u2013 knowledge of ICH and FDA guidelines for API manufacturers and their application, and\/or relevant Quality system certification.
\n\tExperience in batch record review, batch release, and quality documentation.
\n\tMust be computer literate, MS Windows, i.e., Word, Excel, PowerPoint, Teams, Adobe, etc.
\n\tValidation, Regulatory, Quality Assurance, Quality Control and Production experience will be advantageous.<\/p>\n
Competencies\/Personal Attributes<\/p>\n
\tObservation \u2013 ability to observe and evaluate processes and procedures.
\n\tExcellent organizational and administrative skills.
\n\tExcellent problem-solving skills.
\n\tAttention to detail \u2013 proofreading and auditing.
\n\tAbility to work independently.
\n\tAbility to interpret regulations and take initiative.
\n\tConfident to address adverse issues at all levels of the business.
\n\tGood interpersonal skills.
\n\tApplication of critical thinking to quality decisions.
\n\tEffective communication and technical writing skills.<\/p>\n
Apply via company website ( ) or<\/p>\n
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