Executive / Asst. Manger Quality Control

Job Description

Key Responsibilities (State the primary duties and tasks of the position)
Core Responsibilities:

• Performing routine analysis in the lab on semi-finished and finished samples, etc. in compliance with good manufacturing practices and good
laboratory practices
• Face FDA Inspections and other Audits and able to act as Representative/Lead auditee from QC Department during FDA
Inspections/Audits/Customer GMP Audits
• Approving batches and incoming raw materials and classifying their physical and chemical identity
• Conducting physical inspections in the department
• Assisting in the preparation of specifications, general and standard test procedures
• Reviewing categorization of samples and parameters to ensure instrument calibration is as per schedule
• Performing testing of batches/samples for which complaints are received
• Assisting in investigating root-cause of deviation and identifying corrective and preventive action
• Checking and inspecting the upkeep of instruments, equipment, etc.
• Troubleshooting of malfunctioning instruments
• Operating and maintaining all analytical instruments
• Testing in-process/input raw materials, packing materials, in-process samples and finished products Testing process validation samples, product
stability samples and cleaning validation samples (rinse samples/swab samples, etc.)
• Reviewing documentation and ensuring all in-process checks are carried out as per the SOP.

Competence (Skills, knowledge, experience and attributes required)

Competence Essential
Education •
A graduate in Pharmacy or Pharmaceutical Chemistry, with at least eighteen months practical experience after the graduation in the testing (chemical & Instrumental analysis) of drugs (APIs) in Indian State FDA Licensed Premises; or a graduate in Science (Chemistry as a
principal subject), having practical experience in the testing (chemical & Instrumental analysis) of drugs (APIs) after graduation, in Indian State FDA Licensed Premises

The candidate must be FDA Approved as QC chemist/Testing Staff for chemical & Instrumental analysis on Bulk drugs

Work Experience 10 ~ 15 Years of Relevant Experience

Knowledge & Skills
•In-depth understanding and knowledge of good manufacturing practices, good laboratory practices, including Stability testing and Analytical Method validation is as per Pharma norms
•Knowledge of documentation as per GMP and QMS guidelines
•Ability to perform QC data reporting
•Good knowledge in pharmacopeia (eg General testing requirements given in USP)