Senior Research Associate

Role & responsibilities

• Managing the day-to-day operation of the concerned department in a complying and in safe manner.
• Preparing and issuing the job descriptions to the concerned team member.
• To ensure that only current and authorized documents are being used in the department.
• Verification of log books and raw data. Verifying the accuracy and validity of technical data, ensuring its proper recording and archiving.
• Review of method development, verification, validation, protocols, reports and raw data. Supervise and participate in developing, validating, and transferring analytical methods for drug product testing.
• Ensure all testing procedures comply with established protocols, maintaining quality control measures.
• To ensure the proper intimation and follow-ups with the external service persons in case of any equipment breakdown, preventive maintenance, any calibrations etc. Ensuring the availability of adequate equipment and instruction for operation, calibration, intermediate checks and maintenance and implementation of them.
• Ensuring the laboratory staff work allotment, the supervise laboratory staff, ensuring proper training, scheduling, and performance evaluation.
• Oversee test results, reports, and protocols documentation while ensuring accuracy and compliance with regulatory requirements.
• Keep abreast of cGMP guidelines and ensure the laboratory operations comply with regulatory standards, including FDA and other relevant agencies.
• Review and analyze data obtained from testing procedures, ensuring accuracy, integrity, and compliance with established specifications. Preparation and review of test reports and COAs.
• Develop, update, and maintain Standard Operating Procedures (SOPs) for analytical testing processes in line with cGMP guidelines.
• Prepare for and participate in internal and external audits and inspections, facilitating the smooth conduct of these processes.
• To ensure the active participation in investigation of root cause for the customer complaints received against the results issued by the department and to ensure the implementation of necessary corrective and preventive actions promptly.
• To ensure that incident is raised for all the out of specification results from the concerned department and to conduct the supervisor level investigation of the same and to report the same to quality assurance department for further investigation.
• Ensure thorough documentation of laboratory failures, deviations, and investigations in compliance with cGMP requirements
• Conduct risk assessments related to laboratory incidents and failures, communicate findings, and propose strategies for risk mitigation to management
• Oversee and ensure the implementation of effective CAPAs resulting from investigations, ensuring preventive measures to avoid recurrence.
• Conduct a calendar for technical training sessions or workshops to increase awareness among laboratory staff about incident reporting, OOS, and investigation processes.
• Participate in and contribute to management review meetings, presenting findings related to laboratory incidents, failures, and investigations.
• Communicate effectively with other relevant groups, including but not limited to Quality Assurance, HR but not limited to.
• Ensuring the availability of adequate equipment and instruction for operation, calibration, intermediate checks and maintenance and implementation of them.
• Ensure the availability and validity of required Reference standards with the department.
• To maintain the availability of required consumables and conduct the necessary checks to ensure the proper quality of supplies.
• To review the request for testing and proper registration of them.
• To maintain the availability of required consumables and conduct the necessary checks to ensure the proper quality of supplies.
• To verify the raw data/records submitted by the analysts for its completeness, compliance to the requirements and its traceability before releasing the results.
• Be authorized signatory for the reports in their specific area of specialization.
• To provide the technical inputs to the customer care departments to the queries raised by customers.
• To be reviews of documents the calibration, qualification of Instrument / Equipment.
• To ensure the compliance as per regulatory requirements of cGLP/cGDP in the laboratory.
• To ensure the laboratory up-keep and to check and ensure that adequate safety measures are followed in the lab all the time.
• To be maintain data integrity and follow ALCOA ++ principles.
• To ensure timely submission of records for archival to QA department.
• Any other works assigned by HOD / Designee / Reporting Manager.
• Liaison with QA department in relation to quality matters affecting the testing.
• To be maintain confidentiality of the laboratory activities.
• To be ensure calibration / maintenances schedules.
• To assist to concerned manager and to prepare and review the documents of QMS for relevant technical matters.
• To be ensure Internal audits, trainings but not limited to, schedules.

Preferred candidate profile

• Bachelors or Master’s degree in

  [Any Relevant discipline: Pharma, Chemistry, Sciences.]

  .
• Strong analytical skills and ability to interpret research findings.
  
• Experience with HPLC, GC, LCMS preferred.
  
• Excellent written and verbal communication skills.
  
• Ability to manage multiple tasks, meet deadlines, and work collaboratively in a team environment.
  
• Attention to detail and strong organizational skills.
  
• Prior research experience or internship is an advantage.