Title:  Jr. Specialist - QA

Position Summary :

 

  1. In this role you will be responsible for adhering to and ensuring compliance with cGMP principles and maintaining them in an effective manner.
  2. Perform in-process quality check activities according to SOP in production / packaging departments (Tablets/Capsules/liquids/Semi solids/Injectable) in complying with cGMP principles and captures test results in batch records. 
  3. Check the required tests for all products during production / packaging process.
  4. Inspect and check incoming materials by confirming specifications and return unacceptable materials.
  5. Revise all documents for in process control and perform a quality review of logbooks.
  6. Responsible to revise and document for inspection results and complete all required documents for in process control by completing reports and logs, summarizes re-work and waste, and inputs data into quality database on SAP system.
  7. Ensure the in-process check equipment’s are adequately calibrated and functions properly.
  8. Perform and check the line before start (production/packaging) and give the clearance for the work.
  9. Perform Initial investigations for reported incidents and deviation in the respected site
  10. Participate in the preparations of APQRs of the respected site.
  11. Maintain safe and healthy work environment by following standards and procedures and complying with regulations.

Core Competency :

 

  1. In terms of competency, you are highly result oriented with strong sense of accountability & ownership.
  2. High on compliance adherence, having strong attention to detail, proactive and flexible
  3. Good communication, interpersonal, and collaboration skills.
  4. Should be having good learning agility to understand and grasp new learnings.
  5. Motivated, organized, focused & overall compliance.
  6. Must be able to manage tasks, plan workload effectively, priorities and easily adapt to changing situations.
  7. Ability to understand new learnings and implant in workplace.

Qualifications, Key Experiences / Functional Knowledge Requirements:

 

  1. Bachelor of degree in pharmacy/Science
  2. Minimum 0 to 3 years in quality operation in Sterile manufacturing
  3. Knowledge of QMS system “Agile, Track wise, Ampelogic”
  4. Proficient in English.
  5. Quality and Business decisions taker
  6. Good Knowledge and command on cGMP
  7. Risk Assessment knowledge