Join to apply for the QA Compliance Inspectors role at Aspen Pharma Group
Join to apply for the QA Compliance Inspectors role at Aspen Pharma Group
Fine Chemicals Corporation requires the services of QA Compliance Inspectors for our Quality Assurance Department.
Overview
- Responsible for ensuring that all manufacturing activities at the facility comply with current Good Manufacturing Practices (cGMP), regulatory requirements, and internal quality standards.
- To provide oversight of batch documentation, batch release, audit readiness, OTIF (On-Time In-Full) support, and plant floor compliance monitoring.
- Collaborate with production, QC, and engineering teams to ensure GMP compliance and product quality.
- Promote a culture of quality and compliance across operations.
Responsibilities
Review and approve Batch Production Records (BPRs), cleaning logs, and associated documentation.Ensure completeness, accuracy, and compliance of batch records with regulatory and internal standards.Evaluate and close deviations, CAPAs, and change controls related to batch production.Make informed decisions on batch release, ensuring product quality and regulatory compliance.Compile, maintain and drive traceable and auditable batch release documentation.Collaborate with the relevant operational teams to support timely batch release.Prioritize QA activities to align with production schedules and delivery commitments.Identify and mitigate quality-related risks that could impact OTIF performance.Monitor and report on QA-related OTIF metrics and drive continuous improvement initiativesTrain new staff members on SOPs in transition period (including GMP induction).Perform GMP training to support adherence to the GMP training schedule.Identify refresher or awareness training needs across the site.Prepare for and support internal audits, regulatory inspections (e.g., SAHPRA, FDA, etc.), and customer audits.Track and close audit findings and ensure timely implementation of corrective actions.Maintain audit readiness across all departments.Monitor manufacturing operations to ensure compliance with cGMP, GxP, and internal SOPs.Conduct routine inspections and compliance walkthroughs on the production floor.Provide real-time QA support during critical manufacturing and cleaning operations.Ensure plant floor activities align with quality and safety standards.Risk assessment participation, review and approval.Support IQ / OQ / PQ activities pertaining to validation.Review and approve cross contamination assessments.Perform, review and approve line clearance authorizations.Support the implementation and maintenance of the site’s Quality Management System (QMS).Participate in investigations of non-conformances and implement corrective and preventive actions.Independently assess deviations and non-conformances and make timely quality decisions.Ensure data integrity and compliance with ALCOA+ principles across all quality records.Assist in the development and revision of SOPs, work instructions, and training materials.Write, review and approve technical reports related to deviations, CAPAs, and change controlsBackground / Experience
Skills Required
Minimum a tertiary qualification - bachelor’s degree in pharmacy, Chemistry, Microbiology, Biochemistry, or Chemical Engineering (NQF Level 7 or 8).cGMP and QMS experience - knowledge of ICH and FDA guidelines for API manufacturers and their application, and / or relevant Quality system certification.Experience in batch record review, batch release, and quality documentation.Must be computer literate, MS Windows, i.e., Word, Excel, PowerPoint, Teams, Adobe, etc.Validation, Regulatory, Quality Assurance, Quality Control and Production experience will be advantageous.Competencies / Personal Attributes
Observation - ability to observe and evaluate processes and procedures.Excellent organizational and administrative skills.Excellent problem-solving skills.Attention to detail - proofreading and auditing.Ability to work independently.Ability to interpret regulations and take initiative.Confident to address adverse issues at all levels of the business.Good interpersonal skills.Application of critical thinking to quality decisions.Effective communication and technical writing skills.Suitably qualified applicants are invited to submit their CV’s online on or before the specified date. Preference will be given to applicants from designated groups in accordance with laws governing employment equity, where such laws are applicable to the Aspen entity that will employ the successful candidate. If you have not heard from the HR department within 30 days of this advert closing, please consider your application unsuccessful.
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Seniority level
Seniority level
Associate
Employment type
Employment type
Full-time
Job function
Job function
Health Care Provider
Industries
Pharmaceutical Manufacturing
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