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).