Quality Assurance Specialist

3 weeks ago


Karachi, Sindh, Pakistan Convenience Food Industries (Pvt) Limited Full time

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Direct message the job poster from Convenience Food Industries (Pvt) Limited

Oxford University Sustainable Urban Development MSc. Candidate

We are seeking a highly competent, systems-oriented, and audit-ready Quality Assurance Specialist to lead our factory's compliance, documentation, and testing operations. This is a pivotal leadership role in ensuring product quality, batch traceability, and system compliance across food-grade environments aligned with GLP, GCP, GMP, ISO 22000, HACCP, CODEX, ASTA, FSA, and ICH Q10.

This position combines technical depth in QA/QC processes with cross-functional leadership across production, lab testing, regulatory affairs, and QMS improvement.

ROLE PURPOSE

To develop and oversee the implementation of robust quality systems, digital documentation, regulatory readiness, and internal audit controls, while ensuring all products meet national and international regulatory standards, from batch release to data integrity.

KEY RESPONSIBILITIES

QA/QC Leadership & Regulatory Compliance

  • Lead QA systems aligned with GLP, GCP, GMP, ISO 22000, BRCGS, HACCP, CODEX, FSSC 22000, ASTA, and ICH Q10
  • Oversee batch release reviews, material approval, deviations, OOS, CAPAs, and document control
  • Conduct audits of manufacturing processes, labs, and documentation to maintain audit-readiness
  • Interface with regulatory agencies and support inspection readiness for local and international bodies
  • Own and continuously improve the Quality Management System (QMS) with cross-departmental integration

Lab Operations & System Integration

  • Lead QC testing operations, including raw material, in-process, and finished product testing
  • Manage lab workflows using LIMS, Empower, Chromeleon, and other CDS systems
  • Ensure compliance with 21 CFR Part 11 and data integrity standards (ALCOA+)
  • Supervise reagent preparation, test method validation, and calibration control
  • Maintain traceability, secure data access, and compliance in all electronic laboratory records (ELR)

SAP & Digital Quality Infrastructure

  • Utilise and maintain SAP QM modules for batch records, testing data, approval workflows, and analytics
  • Lead digitisation of QA records, dashboards, test plans, and inspection results using SAP, Google Sheets, or QA software
  • Validate data inputs, exports, and audit trails across SAP and lab systems
  • Experience with VBA, Visual Basic, or macro programming is a strong plus for QA automation
  • Perform FMEA, Root Cause Analysis, SPC (Statistical Process Control), Control Plan drafting, and deviation trending
  • Use Advanced Quality Planning tools to improve incoming inspection, sampling, and control measures
  • Coordinate with production and R&D for process improvements and technology transfers
  • Lead CAPA boards and monitor QA KPIs across rework rates, complaint resolution, and audit observations

People Development & Quality Culture

  • Manage and mentor QA/QC analysts, documentation officers, and sampling/lab staff
  • Foster a quality-first mindset across departments through training, coaching, and internal audits
  • Work with Training/HR to ensure new hires are inducted in QA protocols and GxP principles
  • Promote an environment of safety, compliance, collaboration, and continuous learning

EXPERIENCE & QUALIFICATIONS

Education

  • Bachelor's or Master's in Food Technology, Pharmaceutical Sciences, Microbiology or Chemistry

Required Experience

  • 5+ years of experience in Quality Assurance in food manufacturing, pharma or nutraceutical.
  • 3+ years managing QA/QC teams in QMS-driven environments
  • Familiar with LIMS, Empower, Chromeleon, SAP QM, ELNs, and data integrity systems
  • Strong working knowledge of GLP, GMP, GCP, ISO 22000, 21 CFR Part 11, and ICH Q8-Q10
  • Hands-on experience with batch control, deviation management, audit prep, and CAPA closure
  • Experience with FMEA, SPC, Root Cause Analysis, Control Plans, and Six Sigma methodologies
  • Proficient in Microsoft Office (Excel, Word, PowerPoint) and QA-specific software
  • Strong documentation, reporting, and audit-response writing skills
  • Ability to lead cross-functional investigations and resolve quality escalations under time pressure
  • Strong interpersonal skills to collaborate with QA, Production, R&D, Engineering, and Regulatory teams
  • Familiarity with CDS programming (VBA or macro-level automation) is an advantage

If you are a systems thinker with deep QA discipline, compliance foresight, and lab-to-ERP fluency and if you believe quality is not an act, but a system, we welcome your leadership.

Seniority level
  • Seniority levelMid-Senior level
Employment type
  • Employment typeFull-time
Job function
  • Job functionQuality Assurance
  • IndustriesManufacturing

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