• The Manager – Quality Assurance is responsible for overseeing internal audits and quality systems. He will be evaluating the effectiveness of internal controls, risk management, and compliance with applicable regulations and company policies. The role also focuses on driving continuous improvement, ensuring regulatory readiness, and supporting cross-functional initiatives to enhance operational quality and mitigate risks.

What to expect:

• Provide strategic leadership for the implementation and maintenance of the Shalina Quality Management System (QMS) across the site to ensure compliance with corporate and regulatory requirements.
• Approve key quality documents including APQR, Site Master File (SMF), Validation Master Plan (VMP), Process Validation (PV), and Cleaning Validation (CV) , in alignment with SHNL QMS policies.
• Lead risk identification and assessment initiatives, and implement effective mitigation strategies to address potential quality and compliance gaps.
• Manage the investigation of market complaints , ensuring timely implementation of robust CAPAs and conducting periodic effectiveness reviews .
• Approve critical documents such as Master Batch Manufacturing Records (MBMR), Master Batch Packing Records (MBPR), and in-process specifications to ensure accuracy and compliance.
• Oversee the review and approval of Change Controls, OOS/OOT investigations, Deviations, and Rejections , ensuring thorough root cause analysis and sustainable CAPA implementation.
• Lead the review and continuous improvement of quality manuals, policies, SOPs , and related documents to reflect current regulatory expectations and best practices.
• Define and execute the site-wide training strategy for QA staff and plant personnel to build and sustain a quality-first culture.
• Review and publish the monthly Quality Index for the QA function and the manufacturing site.
• Lead the internal audit/self-inspection program , ensuring audit readiness at all times and timely closure of identified gaps.
• Oversee regulatory and customer audit preparedness , lead audits, and ensure timely submission of comprehensive compliance reports .
• Ensure the site is maintained in a constant state of regulatory readiness , aligned with both internal and external quality standards.

Experience & Skills

• 15+ years of experience in Quality Assurance with PGD Analytical & Environmental Chemistry.
• D eep understanding of ISO (e.g., SAHPRA, PICs, WHO, ISO 9001, ISO 13485), GxP, GMP, FDA, ICH, or other applicable regulatory frameworks depending on the industry.
• Proficient in implementing, auditing, and maintaining QMS frameworks
• Ability to investigate non-conformities and identify systemic issues
• Strong writing skills for audit reports, SOPs, and compliance documentation
• Strong problem-solving mindset to assess data, detect patterns or risks, and draw meaningful conclusions.
• Deep understanding of relevant industry regulations.
• Effectively communicates audit findings and compliance issues across all organizational levels