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Quality Assurance Manager

Briyosis Soft Caps Pvt. Ltd.

3 - 5 years

Vadodara

Posted: 24/12/2025

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Job Description

1. Position Overview

The Quality Assurance Manager supports the Head of Quality in implementing and maintaining the Quality Management System (QMS). This role is responsible for GMP compliance, batch documentation review, and routine quality oversight across the facility. The position suits a candidate with around3+ years of QA experience who is ready to take on managerial responsibilities in a growing nutraceutical/softgel manufacturing environment.


2. Key Responsibilities


A. GMP Compliance & Quality Systems
  • Monitor GMP and GDP compliance on the shop floor.
  • Support management of deviations, change controls, CAPA, and risk assessments.
  • Assist in internal audits and help ensure timely closure of audit findings.
B. Batch Documentation & Release Activities
  • Review BMRs and BPRs for completeness and compliance.
  • Coordinate with Production and QC for smooth batch release.
  • Ensure proper maintenance of logbooks and adherence to data integrity practices.
C. SOP & Documentation Management
  • Draft, revise, and maintain SOPs and controlled documents.
  • Ensure Good Documentation Practices (GDP) across departments.
  • Manage document control systems under the guidance of the Head of Quality.
D. Material & Vendor Support
  • Review COAs, vendor documents, and relevant technical data.
  • Support Procurement and QC in vendor qualification processes.
  • Participate in supplier assessments when required.
E. Training & Compliance Support
  • Conduct basic GMP and documentation training for staff.
  • Monitor routine compliance in production, stores, and QC.
  • Escalate non-compliances and initiate corrective actions.
F. Investigations & CAPA Coordination
  • Assist in investigations related to deviations, OOS/OOT, and product complaints.
  • Ensure CAPAs are documented, followed up, and closed within timelines.
G. Cross-Functional Coordination
  • Work with Production, QC, Stores, and Engineering to resolve quality issues.
  • Provide QA support during equipment qualification, validation, and line clearance activities.


3. Skills & Competencies
  • Strong understanding of GMP, GDP, and basic QMS elements.
  • Good knowledge of nutraceutical/pharmaceutical operations (softgels beneficial).
  • Strong documentation and compliance-monitoring capabilities.
  • Good communication, training, and coordination skills.
  • Ability to handle routine QA tasks independently while escalating major issues appropriately.
  • Familiarity with FSSAI, WHO-GMP, or AYUSH requirements is preferred.


4. Qualifications & Experience
  • Bachelors or Masters degree in Pharmacy, Chemistry, Life Sciences, or equivalent.
  • Minimum 3 years of experience in QA within pharmaceutical or nutraceutical manufacturing.
  • Experience in batch documentation review and basic compliance activities.
  • Exposure to audits or regulatory inspections is an added advantage.


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