Prepare and manage documentation for regulatory compliance. Maintain accurate records and ensure proper filing and retrieval systems. Coordinate with various departments to gather required documents. Review and verify the accuracy of documents before submission. Ensure confidentiality and security of sensitive information.
Execution and planning of compression / Coating / Capsule activity Troubleshooting of compression manchine / Coating machine / Capsule filling Recording of BMR, daily document, cleaning record, issuance of issuance of change part Exposure of audits (EU - GMP/ WHO / ROW / USFDA) Maintain the cleaniliness of area. Aware about the concept of GMP/GDP/Data integrity. Handling manpower
Key Responsibilities Validation Strategy & Documentation Prepare comprehensive validation protocols, reports, and master plans for various dosage forms including OSD, oral liquids, and topical formulations. Define validation strategy in line with current regulatory expectations and industry best practices (e.g., FDA, EMA, WHO). Implement a life cycle approach to validation covering development, execution, monitoring, and revalidation. Cleaning Validation Execute and oversee cleaning validation activities . Select worst-case products based on matrixing, carry out swab and rinse sampling. Design and validate sampling plans , calculate MACO, and determine acceptance criteria. Prepare and review cleaning validation protocols and reports. Process Validation Conduct process validation (PV) for new and existing products. Draft and execute validation protocols including BMR/BPR reviews. Participate in risk assessments (e.g., FMEA) and root cause analysis as needed. Equipment & Utility Qualification Prepare and execute protocols for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) . Perform equipment and utility qualifications (HVAC, purified water systems, compressed air, etc.). Hold Time Studies Plan and execute hold time studies for bulk, intermediate, and finished products. Analyze data and compile reports in accordance with regulatory expectations. Sampling Plan & Worst Case Matrixing Design effective sampling plans based on worst-case scenarios, product complexity, and manufacturing practices. Perform matrix selection for cleaning and process validation. Compilation & Compliance Ensure end-to-end compilation of validation documentation in compliance with cGMP. Participate in internal/external audits and provide technical support during regulatory inspections. Required Qualifications Bachelor's / Master's Degree in Pharmacy, Pharmaceutical Sciences, or a related field. Minimum 5 years of experience in validation within formulation development (OSD, oral liquids, topical). Sound knowledge of regulatory guidelines (USFDA, MHRA, EMA, WHO, etc.).
Conducting qualitative and quantitative research to gather relevant data. Analyzing data sets to identify trends, patterns, and insights. Preparing detailed reports and dashboards to support strategic decision-making. Data Management : Collecting, organizing, and maintaining large datasets. Ensuring data accuracy, consistency, and integrity. Utilizing various tools and software for data analysis and management. Project Management : Managing research projects from inception to completion. Coordinating with cross-functional teams to ensure project alignment with organizational goals. Monitoring project progress and addressing any issues or challenges that arise
Develop and implement quality assurance policies and procedures. Conduct regular audits and inspections to ensure compliance with standards. Investigate and resolve quality issues and customer complaints. Train staff on quality control processes and standards. Maintain accurate records and documentation of quality activities.
Develop and implement quality assurance policies and procedures. Conduct regular audits and inspections to ensure compliance with standards. Investigate and resolve quality issues and customer complaints. Train staff on quality control processes and standards. Maintain accurate records and documentation of quality activities.
Assist in the formulation and development of new products. Conduct research and trials to improve existing formulations. Collaborate with production and quality teams to ensure product standards. Maintain accurate records of formulations and development processes. Ensure compliance with regulatory and safety guidelines.
Manage and oversee Analytical Development Laboratory (ADL) activities. Develop and validate analytical methods for product testing. Monitor and ensure compliance with regulatory standards and guidelines. Collaborate with R&D and Quality teams to support product development. Prepare and present ADL reports to management. Identify opportunities for process improvements and innovation.