QC Documentation Associate

The QC Documentaion Associate will be responsible for the activities related to QC Documentation, sample management for finished product and stability testing and sending samples to outside labs for testing.

Responsibilities:

• Perform sample log-in activity and organize the incoming samples for testing.
• Co-ordinate to load and pull the stability samples from the chambers.
• Periodically check for the expired chemicals and separate them for destruction.
• Send samples to third party labs for Micro testing.
• Organize the Laboratory related documents and maintain/submit the documentation to QA for archival as and when required.
• Receive and load the stability samples into the respective stability chambers as defined in the Approved Protocols.
• Prepare the stability sample pull schedules, Pull the samples at the respective time intervals and submit to the sample login in-charge and notify to the concern team leads. Circulate the monthly stability schedule to the team leads.
• Any changes in stability schedule/any discontinue in stability program need to coordinate with the team leads and circulate the respective document for approval.
• Remove the additional/retain samples from the stability chambers during the last time point pull and discard the samples appropriately.
  For control substance stability samples inventory should be maintain throughout the stability program.
• Periodically review and update the stability SOP s and related documents to in line with the current ICH guidelines.
• Maintain the Working standards/Reference standards/Impurities/sample inventory which required for analysis.
• Place the lab chemicals, standards and consumable orders as and when required.
• Comply with all regulatory/in-house requirements (may include but not limited to safety, house keeping, laboratory chemical waste, cGMP, cGLP, documentation) when performing the assigned activity.

Education:

• Minimum Bachelor's degree in relevant field (Chemistry preferred).