1. Harmonization of the MSN API division QA SOPs and Formats as Corporate procedures to fulfill current Global Regulatory Guidelines and requirements.
2. Preparation, Distribution of the CQA SOP or Format to the respective sites.
3. Making sure that Change controls are raised wherever necessary and Impact assessment evaluation and approved by concerned departments, Head-CQA and maintenance of Change control log books.
4. Responsible for monitoring the implementation of the Established procedures across the sites.
5. Extending support to site QA for regulatory Inspection preparation as required.
6. Responsible for document control activities and document distribution to the user departments.
7. Issuance, Archiving and Retrieval of all GMP documents and retaining the documents as per the requirements.
8.



Issuing of registers for all applicable departments maintaining of records for the reconciliation.
9. Identification of the gaps in the existing procedures and practices by reviewing the available Procedures or Practices across the MSN API sites Vs the available regulatory Guidelines for the respective activity during the CQA audit.
10. Work as per guidance from CQA head for the identification of the gaps in the existing procedures and practices by reviewing the available Procedures or Practices across all API Units Vs the available regulatory Guidelines such as ICH, 21 CFR, EU, WHO etc. for the respective activity.

Preferred candidate profile

📌 CQA- Deputy Manager (Patancheruvu)
🏢 MSN Group
📍 Patancheruvu