QA Pharma Job in Sikkim for B.Pharm/M.Sc. Graduates – Apply Now!
Are you a B.Pharm or M.Sc. graduate with a keen interest in Quality Assurance and regulatory compliance? Here’s your chance to kick-start your pharmaceutical career with a leading company in Sikkim. The Junior Team Member – QA role offers hands-on experience in documentation, audit readiness, compliance reporting, and validation, all while working in a GMP-regulated environment. Learn how this opportunity can shape your future in pharma.
About the Company:
As a trusted leader in the pharmaceutical industry, our company is committed to ensuring the highest quality standards in healthcare. We focus on regulatory compliance, GMP adherence, and continuous improvement to deliver safe and effective medicines worldwide. With a robust Quality Assurance team, we drive excellence from manufacturing to market, offering growth opportunities to talented individuals who share our passion for quality and integrity.
Job Details:
Job Posting: Junior Team Member – QA
Posting Date: Jun 16, 2025
Country: India
State: Sikkim
Location: Rangpo
Req Id: 94579
Job Purpose:
Ensure compliance at the site for deficiency responses, prepare master validation protocols, and reports as per company quality policy and regulatory guidelines.
Key Responsibilities:
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Coordinate with SPOCs to collect data and review work plans for regulatory deficiencies.
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Escalate delays and send data to HO for compilation.
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Review and align validation documents across units.
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Conduct annual product quality reviews (APQR) to ensure cGMP compliance.
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Manage regulated market technical agreements and provide execution guidance.
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Distribute approval certificates and development reports.
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Handle regulatory and customer audits, prepare responses, and drive CAPA implementation.
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Track MHRA UK updates and compile raw data for corporate submissions.
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Monitor warning letters and audit observations across units to drive preventive actions.
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Execute applications for product licenses, test licenses, WHO GMP, alcohol quota, and staff approvals.
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Coordinate with FDA for timely processing and communication.
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Support CDSCO and state FDA inspections.
Major Challenges:
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Timely receipt of data from units
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Validation document quality
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Root cause analysis and compliance training
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Government liaison and approval timelines
Key Interactions:
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Regular coordination with unit QA heads, RA teams, FDA, and corporate quality teams.
KPIs:
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100% timeline adherence
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No overdue compliance
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Zero disruptions due to GMP or licensing issues
Education Qualification
- B. Pharma/ M.Sc. with a minimum of three/ four years of experience in the quality assurance department. Licensing and registration (0-2 years)
Relevant Work Experience
Sound knowledge of cGMPs and regulatory guidelines, and basic knowledge of computer systems.
Keywords: Cipla, Job Posting, QA Pharma Job, Junior Team Member, Quality Assurance, Compliance, Regulatory Guidelines
