Officer, CommercialStbltyLab-ARPL-CSA AR

Analysis of Stability samples, Method verification, Method transfer sample and Instrument qualifications as assigned in timely manner.

• Analysis of Stability analysis, Method verification, Method transfer samples as per method of Analysis by adhering to the Regulatory Procedures.


• To be responsible for all activities in the Commercial Stability Laboratory, including cGLP, documentation and implementation of departmental Quality systems.


• Qualification and calibration of analytical instruments as per procedure.


• Performing timely analysis of samples on priority basis.


• To ensure compliance of cGLP by following applicable procedures in Laboratory.


• Compliance to GLP, SOPs, Test Procedures and Protocols etc.


• Participate in the activities ensuring all time audit readiness in the lab.


• Assist in preparation, review and revision of SOPs, test procedures as required.


• Performs all work in accordance with all established regulatory and compliance and safety requirements.


• Coordinating the issues related to the specifications/ worksheets/ other documents with concern department and take efforts to resolve the same immeadiately.Identify the causes and recommend/implement solutions with management oversight.


• Works in a safe manner collaborating as a team member to achieve all outcomes.


• Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.


• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.


• All other relevant duties as assigned by Assistant Manager.

• Education
  
  
  
  • Minimum MSc/BPharm or any equivalent degree.
    
    
    
    
  
  
  
  


• Knowledge, Skills and Abilities
  
  
  
  • Effective command over verbal and written communication with good interpersonal skills.
  
  
  • Command on Microsoft-Office (Word, Excel).
  
  
  • Able to prioritize the tasks.
  
  
  • Best in effective planning of work activities to meet the time lines.
  
  
  
  

• Experience
  
  
  
  • Minimum 1 to 2 years of experience in GMP regulated Pharmaceutical Industry.