1. To issue and control all the GMP documents.
2. To receive back and archive all the GMP documents
3. To maintain the inventory of GMP documents in up-to-date condition
4. This is a very important function as a custodian of the GMP records and his role becomes very important at the time of Audits to retrieve the documents quickly and to provide to the auditor as requested by the auditor.
5. To manage the retain sample room and to archive all the samples of FP and RM till the storage period so that the samples can be issued as and when required for various purpose as handling customer complaints etc
• This position reports to Sr.Manager QA and do not have any direct reports.
1. To perform all activities related to Document control and Retain Sample Management, which are listed below (however not limited to)
2. Scanning and preserving all Master documents (Protocols, Batch Manufacturing Records, Batch packaging records, etc.)
3. Ordering and Maintain the inventory of all the logbooks
4. Issuing the copies of required documents to the user department as and when needed
5. Archiving all the executed documents, cataloging of all the archived documents, storing all the documents in an orderly manner that permits ease of retrieval
6. Prepare and issue all required labels for the production, validation sampling and miscellaneous labels.
7. Maintaining track of document given for reference from the document cell to various department and making a follow-up to collect them back
8. Scanning and preserving all the key documents in the control drives, as to impart ease of sending outside and when required
9. Interacting with regulatory department and providing the required documents to regulatory department as requested
10. Interacting with customers / contract givers and providing the required documents to customers / contract givers as requested
11. Listing, Segregating and arranging for destruction of documents post its storage period
12. Extending support during customer and / or regulatory audits by providing all the documents required during audits in a timely manner
13. Assisting in data collection and APQR preparation
14. Receiving and storing all the retain samples as it comes from different department
15. Preserving a record of all the retain samples
16. Performing periodic visual inspection of the retain sample
17. Listing, segregating and disposing of the samples post storage period on a regular basis
Specialized Skills and Knowledge:
1. Minimum Associate degree with Chemistry as a major with 2- 3 years of experience of document control work or any other QA role of a pharma company
2. Knowledge general documentation practice of a pharma industry.
3. Knowledge of 21CFR Part 210 and 211 and relevant guidelines related to documentation
4. Able to work efficiently on computers – MS Office.
1. Analytical Skills
2. Record Keeping
3. Communication Skills in English
While performing the duties of this job, the employee is regularly required to mover around the production floor. The employee is regularly required to move around various buildings of Avet. The employee must occasionally lift and or move up to 25 pounds.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Avet is proud to be an Equal Opportunity Employer.
This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs.
|Job Category||Quality Assurance|