We are looking for an experienced and detail-oriented Senior Executive – Quality Assurance to join our Quality team. The ideal candidate will be responsible for ensuring compliance with cGMP, SOPs, regulatory guidelines, and quality systems across manufacturing and packaging operations. The role requires strong exposure to documentation, audits, investigations, and process compliance.
- Ensure implementation and compliance of cGMP, GDP, SOPs, and quality standards in manufacturing and packing areas.
- Review and approve BMR, BPR, logbooks, protocols, reports, and quality documents.
- Handle deviation, change control, CAPA, incident, and market complaint investigations.
- Conduct line clearance, in-process checks, and shop floor QA activities.
- Review and monitor batch release documentation before final disposition.
- Support internal, external, customer, and regulatory audits.
- Prepare and review SOPs, validation protocols, qualification documents, and reports.
- Coordinate with Production, QC, Engineering, and Warehouse teams for quality compliance.
- Ensure timely closure of observations, deviations, and CAPAs.
- Participate in self-inspection and quality risk assessment activities.
- Maintain documentation as per regulatory requirements and data integrity norms.
- Strong knowledge of Quality Assurance systems
- Good understanding of pharmaceutical GMP guidelines
- Experience in deviation, CAPA, change control, and audit handling
- Strong documentation and review skills
- Good communication and coordination abilities
- Knowledge of regulatory compliance and validation documentation
- Experience in pharmaceutical manufacturing plant
- Exposure to regulated markets / audit compliance
- Strong analytical and problem-solving skills
- Team handling and coordination experience preferred
Skills Required
- 4-7 years of professional experience
- Bachelor of Pharmacy, Master of Pharmacy, or Master of Science degree
- Strong knowledge of quality assurance systems
- Understanding of pharmaceutical GMP guidelines
- Experience handling deviations, CAPA, change controls, and audits
- Strong documentation and quality document review skills
- Knowledge of regulatory compliance and validation documentation
- Experience in a pharmaceutical manufacturing plant
- Exposure to regulated markets and audit compliance
- Strong analytical and problem-solving skills
- Team handling and coordination experience
What We Do
Nitika Pharmaceutical Specialities Pvt. Ltd. is an India-based pharmaceutical manufacturer and exporter founded in 1991 and headquartered in Nagpur. The company specializes in pharmaceutical excipients, antacid active ingredients, mineral salts, and related formulation materials. Its products support pharmaceutical manufacturing worldwide, with distribution reaching more than 90 countries across regulated and emerging international markets. Nitika emphasizes innovation, quality, patient focus, integrity, teamwork, and value-driven operations.
