openings for QA,QC

QA Specialist, LOT Disposition:

• Coordinate and perform drug substance and drug product lot final review & disposition activities in accordance with procedures, performance measures, and standard lead times.
• Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
• Collaborate with departments to ensure that all review activities are executed efficiently and effectively, Train personnel and internal customers on relevant business processes, Serve as a technical subject matter expert (SME) in support of department functions.
  

Requirements: 

• Degree in Science with atleast 3 years of experience in pharmaceutical, biotechnology or related industry,
• Knowledge on cGMP or equivalent regulations
• Able to interpret and relate quality standards for implementation and review and communicate well both verbally and written. 
  

QC Specialists:

• Analysis of environmental, raw-b Support
• Documentation of results in accordance with current Good Manufacturing Practices (cGMP)
• Design and execute quality investigations and CAPA ( Corrective actions Preventive actions)
• Author or update existing SOPs and TMs as needed, IDentify gaps in and potentials improvements to systems and procedures,
• Undertake specific areas of responsibility
  
  • Microbiology / EM area: Execute basic micro and intermediate techniques.
  • Analytical / biochem area: Execute basics of Spectroscopy and Assigned methods which may include chromatograph methods, ELISA, PCR, Osmolality etc.
  • Raw materials Area: Execute compendial monograph as well as chemistry fundamentals methods.
    

 Requirements: 

• Degree in Science ( Biochemistry or  Microbiology with atleast 3 years of revelant experience , lab experience in a biotech or medically field with CGMP knowledge is preferred.
• Good Problem solving and analytical skills with good communications