Advanced Chemical Industries PLC (ACI)
Requirements
Education
- Master of Pharmacy (M.Pharm)
Experience
- At most 3 years
- The applicants should have experience in the following business area(s): Pharmaceutical/Medicine Companies
- Freshers are also encouraged to apply.
Additional Requirements
Experience in Development QA, R&D QA, QA, QC, or Product Development of any pharmaceutical company.
Responsibilities & Context
- Ensure Quality Assurance oversight for new product development, reformulation, technology transfer, scale-up, exhibit, and validation batches.
- Review and approve development-related documents including SOPs, specifications, protocols, analytical methods, batch records, validation reports, stability protocols, and reports.
- Coordinate and monitor Change Controls, Deviations, Incidents, CAPA, Risk Assessments, and Investigation activities related to product development.
- Perform in-process quality monitoring and compliance checks during formulation development, pilot trials, exhibit batches, and technology transfer activities.
- Review and evaluate analytical testing data, stability study results, method validation/verification reports, and development reports to ensure compliance with quality requirements.
- Coordinate new product quality testing activities with R&D, Quality Control, Production, and Regulatory Affairs to support timely product development and submission.
- Ensure compliance with cGMP, GLP, Data Integrity, WHO, USFDA, PIC/S, ICH, DGDA, and other applicable regulatory requirements throughout the product development lifecycle.
- Conduct internal audits, compliance reviews, and quality risk assessments within Development and R&D functions and ensure timely closure of observations.
- Maintain effective document control and ensure proper archival, issuance, and retention of development and quality records.
- Support regulatory inspections, customer audits, dossier preparation, product registration activities, and successful commercialization of new products.
To apply for this job email your details to apply@chakricircular.com