Chemical Manager

The role involves providing comprehensive support to the Quality Control Manager in overseeing and managing Quality Control activities related to Cleaning Validation, Computer System Validation, and the Annual Product Quality Review (PQR) process. The position requires coordination with multiple stakeholders to ensure timely execution of quality initiatives and adherence to regulatory guidelines. The incumbent will play a key role in data collection, analysis, and reporting, while also supporting various validation activities and quality assurance processes across departments.

Key Responsibilities

- Prepare and implement the Annual Product Quality Review (PQR) plan, ensuring all activities are completed within the scheduled timeframe.
- Collect, review, and analyze PQR-related data from all relevant stakeholders. Prepare detailed PQR reports highlighting findings, observations, and trends.
- Communicate PQR outcomes to respective departments and senior management to facilitate appropriate corrective and preventive actions (CAPA) and recommendations.
- Develop Cleaning Validation Master Plans (CVMP), protocols, and reports, selecting worst-case scenarios in line with current guidelines and site-specific products.
- Oversee Cleaning Validation activities related to products, processes, and equipment, including support for glassware cleaning validation.
- Conduct cleaning validation and revalidation by preparing protocols and documentation as per the Master Plan.
- Manage cleaning validation sampling activities in collaboration with Quality Assurance (QA) teams.
- Revise cleaning validation schedules based on production and supply priorities through consensus with relevant stakeholders.
- Prepare the annual Computer System Validation Master Plan (CSVMP) for QC equipment, ensuring adherence and communicating monthly validation plans to all stakeholders.
- Develop and execute protocols and reports for computer system validation activities.
- Review and align Standard Operating Procedures (SOPs) related to PQR, Cleaning Validation, and Computer System Validation with applicable policies.
- Ensure implementation and compliance with all SOPs, policies, and procedures.
- Review and complete change control tasks associated with Cleaning Validation, Computer System Validation, and PQR.
- Prepare impact and risk assessments as required.
- Provide support to other departments regarding stability programs and data needs related to PQR, Cleaning Validation, and Computer System Validation.
- Review Annual Quality Review (AQR), Line Listing (LL), High Priority Reports (HPR), and other quality projects for assessment and necessary actions.
- Participate as a Subject Matter Expert (SME) in self-inspections, regional, divisional, and AQR audits related to the above areas.
- Implement audit CAPAs promptly for the relevant sections.
- Provide SME support to the Stability Section when required.
- Perform any other duties assigned by the Quality Control Manager or Head of Quality Assurance.

Required Qualifications

- Master’s degree in Chemistry (M.Sc.) or Pharm-D.
- 8 to 10 years of relevant experience in a similar role.
- Strong knowledge of QC/QA requirements, including Cleaning Validation, Computer System Validation, and Annual Product Quality Review processes.
- Proven problem-solving skills related to QC/QA activities.
- Familiarity with validation processes and facility requirements.

Preferred Qualifications and Benefits

- While not explicitly stated, experience with regulatory audits and quality management systems will be advantageous.
- Opportunity to work closely with senior management and cross-functional teams in a dynamic quality environment.

This position demands a detail-oriented professional with a strong background in quality control and validation processes, capable of managing multiple priorities and ensuring compliance with industry standards.