Company Description: Sunil Healthcare Limited is a manufacturer of Empty Hard Gelatin Capsules (EHG Capsules) for the pharmaceutical industry. For further information, visit www.sunilhealthcare.com
ROLE PURPOSE
To strengthen and lead the Quality Assurance and Quality Control function, build a Centre of Excellence in quality, and
support consistent product quality and process control in a 24×7 pharmaceutical manufacturing workplace.
KEY RESPONSIBILITIES
Lead and coordinate QA and QC operations, ensuring adherence to cGMP requirements and the Quality
Management System (QMS).
Maintain process control within defined norms and specifications, including oversight of IPQC and IPQA activities.
Prepare for, coordinate and face statutory inspections and audits, including WHO-GMP and customer audits; ensure
relevant documentation is available and audit-ready.
Oversee pharmaceutical quality documentation and systems, including qualification and validation, SOPs, change
control, deviation management, trend analysis, OOS/OOT investigations and CAPA.
Manage stability studies,
laboratory compliance and validation-related activities.
Ensure appropriate handling and use of QC laboratory equipment and support effective laboratory operations.
Work closely with shop-floor and cross-functional teams to address quality matters and achieve agreed objectives.
Use process-oriented thinking to identify quality or process issues and support appropriate investigation and corrective action.
Lead and develop the QA/QC team while fostering a strong, sustained commitment to quality.
CANDIDATE PROFILE & ESSENTIAL REQUIREMENTS
8–10 years of relevant experience in a process industry operating on a 24×7 basis.
Pharmaceutical industry background, including hands-on exposure to shop-floor operations.
Working knowledge of cGMP, QMS, IPQC/IPQA, process controls and pharmaceutical quality documentation.
Experience in statutory and customer audits, including WHO-GMP audits, and t