Position / Job Title
- General Manager

Department
- DQA

Reporting To
- VP CQA

Location
- Thane

Years of Experience
- 15 to 20

Dosage Form
- Know-how of All dosage form

Job Responsibilities
Development Documentation Management

Approval of MFC, MPC, Specifications, STP, Stability Protocols, Product specific study Protocols, Product Development Reports, Technology Transfer Documents etc.

Approval of various validation study protocols and reports.

Approval of various Analytical Method Validation Studies.

Handling of QMS Elements

Review of various QMS elements like Change Control, Deviations, Investigations, CAPA, OOS/OOT, incidents, market complaints, annual product review and other quality system related documents.

To provide necessary support/investigation for QMS events related to R&D; products, pilot batches, exhibit batches and developmental studies at lab 03, Thane.

Review of various executed documents of exhibit batches manufactured at Various CMOs.

Review of CMO QMS documents and ensure for the timely closure of QMS documents.

Regulatory Compliance





Ensure ongoing compliance of the FDA-compliant laboratory with applicable regulatory and quality requirements.

Review for adequacy of the submission documents e.g., Q1, Q2 Assessments, Study Exemption requests, PDRs, Query responses and product specific data generate at various CMOs etc.

Review of documents of BA/BE Studies of various products.

Management of FDA queries, developing responses with RA, CAPA for preventing recurrence of comments for subsequent products.

Review of various executed documents of exhibit batches prior to regulatory submission for ANDA consideration.

SOP’S and Guidance documents

Review and approval of different department (FD, AD, DQA, Store etc.) SOP’s and guidance.

Track the effectiveness of SOP’s/Guidance’s and ensure necessary revisions on need basis as part of system improvement.

BA/BE batch documents review, batch monitoring and release

Review and approval of mas

📌 General Manager (Thane)
🏢 Rubicon Research
📍 Thane