{"id":3887097,"url":"https://alion.io/job/interdot-quality-assurance-operations-department","title":"Quality Assurance Operations Department","company":{"id":4521405,"name":"Interdot","domain":"interdot.co.za","url":"https://alion.io/company/interdot-co-za","size_band":"1001-5000","is_staffing_agency":true,"employer_type":"agency","is_intermediary":false,"listed_via":null,"ats_vendor":"Manatal","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":[],"countries":[],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-11-06T19:59:04Z","employer_posted_date":"2026-11-06","last_verified_at":"2026-11-09T17:04:14Z","board_verified":true,"closed_at":null,"days_open":3,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":3},"description":"Quality Assurance Operations Department\nQUALIFICATIONS NEEDED:\nBachelors degree or diploma in Microbiology/ Biotechnology, Pharmacy, or equivalent. NECESSARY\nEXPERIENCE & INDUSTRY KNOWLEDGE:\nAt least 8 years experience in the vaccine/ biotech/ sterile or pharmaceutical manufacturing industry.\nAt least 3 years experience at middle to senior management level in cGMP pharmaceutical manufacturing or equivalent\nExperience in quality and regulatory compliance within a cGMP facility.\nStrong knowledge of sterile manufacturing environments.\nExperience in having faced successful local and international quality audits.\nExperience in business operational planning and participation in developing the departmental budget.\nKEY DUTIES & RESPONSIBILITIES OF THE ROLE:\nFull responsibility for all areas within Quality Assurance Operations sections consisting of Operations, Systems, Training, and Compliance.\nOverall management and implementation of specified QA processes and document systems including Deviations, CAPAs, Change Controls, National Regulatory Audits Quality Risk Management, and Track wise Management.\nReview and approve documentation within defined timelines as stated in SOP.\nEnsure that procedures and specifications are appropriate and followed including the procedures and specifications of the contract the manufacturers, contract laboratories, etc.\nEnsure that significant changes to the facilities, equipment, and processes, which may affect the quality of products, are validated.\nEnsure that appropriate manufacturing controls are in place, including master manufacturing and packaging documents.\nEvaluate and authorize any re-processing of products or materials.\nEnsure that products are released by buying authorization following full batch and testing record review.\nEnsure that a risk management program and principles are maintained by ICHQ9\nParticipate in the review of the effectiveness of the medicines recall procedure together with the Head of Quality and Responsible Pharmacist.\nReview and approve out-of-specification investigations, out-of-trend investigations, protocols, and reports within defined timelines as stated in SOP.\nReview, approval and sign off all operational documents and records, e.g., System and Component Impact Assessments, GMP reviews, Design qualification, Risk Assessment, IQ, OQ, PQ, periodic re-qualification, Performance testing, Aseptic Process Validation, Process validation, Analytical Methods Validation, Cold-chain Packaging validation, and Cleaning Validation documents.\nincluding both Protocols and Reports to ensure compliance with site approaches, cGMP, and regulatory agency requirements.\nBenchmark against quality standards of the industry and regulatory bodies and create awareness of GMP updates, as appropriate throughout the site.\nOversee customer and regulator audits and ensure tracking and closure of findings, whilst maintaining appropriate communication between Company and auditors.\nAs appropriate, write / review / approve/reject and/or control GMP Documentation and Records to ensure compliance with the requirements of the business, cGMP, and Regulatory agencies.\nEnsure timeous response to customer and regulatory inspections and audit reports.\nManage activities in the Document Control Centre related to providing required documentation and implementing and maintaining related documentation systems\nEnsuring that the document control activities are achieved at the required quality levels (Companys, SAHPRA, and WHO), within the agreed timeframe and ensuring proper management of archived documents.\nMaintain Sterility Assurance aspects on-site including investigations and improvements.\nEnsure that Sterility assurance complies with cGMP and is continuously improved on-site.\nDefines, implements, and owns the site's holistic contamination control strategy.\nEvaluates, improves and owns the site's holistic environmental monitoring program (including utility monitoring).\nLeads, participate, and ensures that all QA engagement/interactions with external third-party stakeholders are timeously held and escalate discussion with the Senior Management team.\nReviews Critical deviations, Investigations, CAPAs, and Risk assessments\nLeads and facilitates all audits on-site inclusive of External Regulatory, third-party customers, new third-party partners, etc.\nParticipate and provide quality oversight within defined projects and delegate project deliverables to staff in sections where appropriate according to skill or development.\nContinuous development and mentorship of the Quality Assurance 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