General Manager

Rubicon Research Limited; Thane; On-site; INR 3,500,000 - 5,500,000; Full time

Job summary

Rubicon Research Limited is seeking a General Manager for the DQA department in Thane. The role reports to the VP CQA and requires extensive R&D/QA leadership with oversight of MFC/MPC approvals, study protocols, validation and QA documentation.

You will drive regulatory compliance, review QMS elements, and coordinate cross-functional teams across formulation and analytical development, audits, and CAPA implementations. A senior professional with 15–20 years of experience is expected.

Qualifications

• Experience in R&D setup either in formulation or analytical development.
• Exposure to regulatory bodies like US FDA, MHRA, TGA.
• Exposure to dosage forms like OSD and Liquid Orals.
• Strong team coordination and work distribution skills.
• Experience with QTAs, PDRs and risk assessment frameworks.

Responsibilities

• Development Documentation Management and approval of MFC, MPC, Specifications and related studies.
• Approval of validation study protocols and reports; QA sign-off on analyses.
• Review of QMS elements (Change Control, Deviations, Investigations, CAPA, OOS/OOT).
• Support for RA activities; respond to FDA queries with CAPA plans.
• Review of exhibit batch documentation and timely closure of QMS records.
• Ensure FDA regulatory compliance for the lab and study documents.

Skills

R&D QA experience

Regulatory exposure (FDA, MHRA, TGA)

Dosage forms knowledge (OSD, Liquid Or

Team coordination

QTAs, PDRs, Risk Assessment

Experience in DQA/QA/R&D (10+ yrs)

Willingness to work in shifts

Site visit to Satara/Amb/Indore

Education

Master's in Chemistry, Biochemistry, B Pharmacy or related field

Job description

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 master and executed BMR/BPR, Review of Coa and Release of BA/BE batch.
• Qualification of equipment in R&D department
• Area and equipment/instrument qualification at R&D site.
• Review of qualification protocols and reports of equipment.
• To support quality activities as and when requires and to support manufacturing plant as and when requires.

Qualifications & Pre-Requisites

Must-Have Skills

• Worked in R&D setup either in formulation or analytical development
• Exposure to various regulatory bodies like US FDA, MHRA, TGA
• Exposure to specific dosage forms like OSD, Liquid Orals
• Team coordination and work distribution
• Exposure to QTAs , PDRs, Risk Assessment
• Master's in chemistry, Biochemistry, B Pharmacy or related field.
• At least total of 10 experiences in DQA, QA and or R&D
• Additional notes Expected to work in all shifts.
• Will have to handle any other responsibility if allocated.
• Expected to visit Satara/Amb/ Indore sites at least once a month on need basis.