Assistant Manager - DQA
Description
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Sr. No.
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Job Responsibilities
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1
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To ensure and facilitate for the timely Review and approval of Analytical method validation Protocols, Reports and Method development reports.
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2 |
Review and approval of new and revised specification and standard test procedure of drug substance and drug product initiated by PTC. |
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3 |
To review the change control form. |
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4 |
To Review and approval of documents like study protocol and report, DMF, Strategy Notes, Decision notes. |
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5 |
To review QbD Compliance during the product development across PTC sites. |
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6 |
To prepare, review and approval of the required Quality Policies, Quality directive and Procedures of Development Quality assurance. |
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7 |
To ensure the justifications provided in the risk assessment during the Product/Analytical development was scientifically justified. |
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8 |
Participation and tracking of Regulatory deficiencies and response Review and approval. |
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9 |
To provide support for Regulatory filling for all markets. |
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10 |
To Review Elemental Impurity compliance reports |
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11
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To Review Nitrosamine Impurity compliance reports |
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12
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Any other work allotted by Head DQA |