Position / Job Title - Sr. Executive

Department - DQA

Reporting To - Sr Manager

Location - Thane

Years of Experience - 5+ years of experience

Dosage Form - Know-how of all dosage form

Job Responsibilities / Deliverables

- Formulation Risk Assessment &
- Scale-Up Support (FD/DQA Interface)
- QRA Technical Evaluation: Technical review and evaluation of Quality Risk Assessment (QRA) reports for current formulation projects as well as major product/process changes. Ensure all potential product quality and process risks are identified early in the development lifecycle.
- CPP &
- CQA Tracking: Critically track the controls proposed in QRA reports. Ensure that Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs) for all dosage forms are adequately addressed and mitigated prior to scale-up and tech transfer.
- FD Collaboration: Act as the primary DQA link for the Formulation Development (FD) team to ensure QbD (Quality by Design) principles are embedded into early-stage development.
- Document Review for Quality Management System (QMS)
- QMS Oversight &
- Review: Manage and review all Thane-related Change Controls, Incidents, Laboratory Investigations, Out of Specification (OOS), and Out of Trend (OOT) QMS documents to ensure absolute compliance and accuracy.
- Verification of Reference Documents: Perform a thorough review of supporting documents and raw data related to investigations to ensure the accuracy of all reference links.
- Cross-Functional Coordination: Maintain close coordination with Cross-Functional Teams (CFTs) to facilitate smooth execution, root cause analysis, and timely resolution of QMS-related activities.
- Timely Closure: Drive the completion and closure of all QMS activities within designated organizational timeframes.
- Trend Reporting:



Compile and prepare metric-driven trend reports related to QMS activities for management review and continuous improvement.
- Calibration, Qualification &
- Laboratory Compliance
- Equipment Qualification Review: Review calibration and qualification data for critical laboratory instruments including HPLC, Balances, pH meters, and Mass Spectrometry (MS) instruments to ensure accuracy and compliance.
- Data Integrity: Demonstrate strong familiarity with 21 CFR Part 11 guidelines to maintain adherence to global regulatory standards.
- Audit Trail &
- Internal Audits: Conduct comprehensive audit trail reviews, perform routine laboratory rounds, and lead internal lab audits to ensure data integrity and maintain strict Lab GMP.
- Regulatory Updates: Stay updated with the latest pharmacopoeia changes (USP/EP/IP) and analytical/formulation regulatory requirements.
- Document Control &
- Operational Support
- Coding &
- Allocation: Oversee the allocation of product codes, National Drug Codes (NDC), and embossing codes.
- Lifecycle Management: Manage the issuance and retrieval of laboratory notebooks, document archival processes, and crown management activities.
- Sample Management: Ensure compliant control sample management within the development facility.

Qualifications &

- Pre-Requisites

- B.Pharm or M.Pharma or MSc in Chemistry is preferred.
- Experience of working in USFDA approved facility shall be preferred
- Experience in working in R&D; will be added advantage
- Know-how of cGMP & good laboratory practices is mandatory.

Additional notes
- Candidate with analytical method validation or formulation development background is preferred.
- Candidate should be ready to work in shifts.
- Candidate shall be ready to travel to outstation sites.

📌 Senior Executive (Thane)
🏢 Rubicon Research
📍 Thane