<\/span>B.Pharm / M.Pharm / M.Sc
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Job Summary
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We are looking for an experienced and detail\-oriented <\/span>Senior Executive \u2013 Quality Assurance<\/b> <\/span>to join our Quality team. The ideal candidate will be responsible for ensuring compliance with <\/span>cGMP, SOPs, regulatory guidelines, and quality systems<\/b> <\/span>across manufacturing and packaging operations. The role requires strong exposure to documentation, audits, investigations, and process compliance.
<\/p>Key Responsibilities
<\/h2>- Ensure implementation and compliance of <\/span>cGMP, GDP, SOPs, and quality standards<\/b> <\/span>in manufacturing and packing areas.
<\/li>- Review and approve <\/span>BMR, BPR, logbooks, protocols, reports, and quality documents<\/b>.
<\/li>- Handle <\/span>deviation, change control, CAPA, incident, and market complaint investigations<\/b>.
<\/li>- Conduct <\/span>line clearance, in\-process checks, and shop floor QA activities<\/b>.
<\/li>- Review and monitor <\/span>batch release documentation<\/b> <\/span>before final disposition.
<\/li>- Support internal, external, customer, and regulatory audits.
<\/li> - Prepare and review <\/span>SOPs, validation protocols, qualification documents, and reports<\/b>.
<\/li>- Coordinate with Production, QC, Engineering, and Warehouse teams for quality compliance.
<\/li> - Ensure timely closure of observations, deviations, and CAPAs.
<\/li> - Participate in <\/span>self\-inspection and quality risk assessment activities<\/b>.
<\/li>- Maintain documentation as per <\/span>regulatory requirements and data integrity norms<\/b>.
<\/li><\/ul>Required Skills
<\/h2>- Strong knowledge of <\/span>Quality Assurance systems<\/b>
<\/li>- Good understanding of <\/span>pharmaceutical GMP guidelines<\/b>
<\/li>- Experience in <\/span>deviation, CAPA, change control, and audit handling<\/b>
<\/li>- Strong documentation and review skills
<\/li> - Good communication and coordination abilities
<\/li> - Knowledge of <\/span>regulatory compliance and validation documentation<\/b>
<\/li><\/ul>Preferred Candidate Profile
<\/h2>- Experience in <\/span>pharmaceutical manufacturing plant<\/b>
<\/li>- Exposure to <\/span>regulated markets / audit compliance<\/b>
<\/li>- Strong analytical and problem\-solving skills
<\/li> - Team handling and coordination experience preferred
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