Sandesh MR

Support QMS Implementation and Maintenance:

Assist in implementing QMS processes and procedures in line with organizational and regulatory requirements.
Ensure that quality control procedures are followed in daily activities, helping to identify gaps or inefficiencies in processes.
Support the maintenance of QMS documentation, including procedures, work instructions, and quality policies, ensuring they are up-to-date and compliant.
Documentation and Record Keeping:

Document processes and outcomes related to quality management activities, ensuring all records are complete, accurate, and accessible.

Track and manage non-conformance reports (NCRs), corrective actions (CAPAs), and other QMS documentation to ensure proper resolution and follow-up.

Ensure that all documentation complies with Good Documentation Practices (GDP) and is available for audits and regulatory inspections.

Corrective and Preventive Actions (CAPA):
Support the investigation and resolution of quality issues by identifying root causes and implementing corrective and preventive actions (CAPA).

Monitor the effectiveness of corrective actions to ensure that issues are resolved and do not recur.

Maintain records of CAPA processes and collaborate with relevant departments to track progress and completion.
Continuous Improvement:

Contribute to the continuous improvement initiatives within the QMS by identifying areas where processes, products, or services can be optimized.

Assist with the implementation of process improvements and best practices within the quality management system.

Analyze data from quality metrics (e.g., defects, customer complaints) to identify patterns and opportunities for improvement.
Training and Competency:

Participate in or assist with employee training related to QMS processes, ensuring that staff are educated on quality procedures and regulatory requirements.

Maintain records of training and certifications, ensuring employees are up to date with required quality standards and practices.

Support the onboarding of new team members and help them understand QMS protocols.

Regulatory Compliance:

Assist with regulatory compliance efforts, ensuring QMS processes align with local, national, and international standards (e.g., FDA, ISO 9001, ISO 13485).

Monitor regulatory changes that may affect the QMS and help implement necessary updates or changes to processes.

Participate in external audits or inspections from regulatory bodies, supporting the QMS team with preparation and documentation.

Risk Management:

Help identify and assess risks associated with processes, products, or services that could affect quality or regulatory compliance.

Support the implementation of risk mitigation plans and monitor their effectiveness over time.

Contribute to risk assessments and decision-making related to quality management.

Quality Metrics and Reporting:

Collect and analyze data related to product quality, performance, and customer satisfaction.

Generate quality reports based on key performance indicators (KPIs) and metrics to track progress toward quality goals.

Communicate key findings and trends to senior management and other departments as needed.
Customer Complaint Handling:

Assist with handling customer complaints related to product quality or service, ensuring that issues are addressed in a timely and effective manner.

Help investigate the root cause of customer complaints and participate in the development of corrective actions to resolve them.
Supplier and Vendor Management:

Support the evaluation and qualification of suppliers to ensure they meet the organization’s quality standards.

Help monitor supplier performance, ensuring that supplied materials or services comply with quality specifications.

Assist with vendor audits to ensure third-party suppliers maintain appropriate quality standards.

Supervision and Leadership:

Assist in managing and mentoring a team of microbiologists and lab technicians.
Ensure the team adheres to quality control processes and meets performance standards.
Oversee daily operations of the QC microbiology department.
Supervise Analytical method validations.
Microbiological Testing:

Ensure that all microbiological testing (e.g., bioburden, endotoxin testing, sterility testing, microbial limit testing) is conducted in accordance with standard operating procedures (SOPs).
Review and validate test results, ensuring accuracy and compliance.
Manage environmental monitoring, ensuring cleanliness and safety standards in laboratory spaces and production areas.
Compliance and Documentation:

Maintain and review accurate records for all microbiological testing and investigations.
Ensure compliance with industry standards (GMP, GLP, ISO, FDA, and other relevant regulations).
Assist in preparing for inspections by regulatory bodies (FDA, EMA, etc.) and audits.
Assist with the preparation and review of validation protocols, test methods, and reports.
Problem Solving and Investigations:

Investigate any deviations or out-of-specification (OOS) results and provide solutions.
Identify potential issues with microbial contamination and take corrective actions to resolve them.
Equipment and Facility Maintenance:

Oversee the maintenance and calibration of microbiology laboratory equipment (autoclaves, incubators, BSC etc).
Ensure that the laboratory environment meets all safety, cleanliness, and regulatory standards.
Training and Development:

Train junior staff and new hires on microbiological techniques, safety standards, and quality control processes.
Update and maintain SOPs for the microbiology department.
Foster a culture of continuous improvement within the team.

Role: Individual contributor/Inoculum development lead
Microbial Culture and Growth Management, Fermentation and Cell Culture, Process Optimization, Inoculum Development and Scale-Up, Quality Control and Assurance, Troubleshooting/Problem-Solving, Data Collection/Analysis, Media Preparation and Sterilization, Plan laboratory batches in line with production schedule, Supervise filter integrity testing, Implement process improvement, Managing of raw material and consumable's stock, Qualification of equipment, Internal auditing, Trend the batch performance, Audit facing personnel, Preparation of SOP and BMR, System upgradation, Procurement of new equipments, Review of BMR, MFR, change control deviation, OOS, equipment failure investigations and Collaborate with CFTs(RnD, Regulatory, Quality, Manufacturing and EHS)

Role: Individual contributor
Microbiological environment monitoring of clean rooms, Water sampling and analysis, Sampling and testing of finished products, Bio burden testing, Growth promotion test, Media preparation and sterilization, Preparation of documents, Handling of microbial isolate libraries, Preparation of microbial cell bank, Maintenance of equipment/logbooks and training of interns.