Data Integrity Officer

1 week ago


Kota, Rajasthan, India Macsen Laboratories Full time
JD - Data Integrity Officer, Permanent Position

Location - Udaipur, Rajasthan, India.

About Macsen Laboratories

Macsen Laboratories, a pharmaceutical and chemical manufacturing organization with its origin dating back to 1952, is engaged in manufacturing of niche Active Pharmaceutical Ingredients, pharmaceutical application dyes, compounds of precious and rare earth metals and other specialty inorganic compounds. Macsen has also started new verticals of Pharmaceutical Analytical Services, Contract Research and Custom Synthesis. Headquartered at the city of lakes, Udaipur (Rajasthan, India) Macsen presently has various manufacturing units in and around Udaipur.

Job Description:

We are looking for a Data Integrity Officer to ensure compliance with data integrity guidelines, GMP regulations, and industry best practices in a pharmaceutical environment. The role involves monitoring, reviewing, and implementing data integrity policies to maintain accuracy, reliability, and consistency in documentation and electronic records.

Key Responsibilities:

• Ensure compliance with GMP, GDP, and data integrity guidelines across all departments.

• Conduct periodic audits and reviews of documentation, electronic records, and laboratory systems.

• Monitor IPQA processes and verify data accuracy in batch records, lab reports, and validation documents.

• Identify gaps and deviations in data handling, storage, and retrieval processes and implement corrective actions.

• Train and guide employees on data integrity policies and best practices.

• Collaborate with the QA, QC, and production teams to ensure regulatory compliance.

• Assist in investigations of data discrepancies and report findings to senior management.

• Maintain and update SOPs related to data integrity and compliance.

Qualifications

• Strong knowledge of GMP, GLP, and data integrity regulations (ALCOA+ principles).

• Experience in IPQA within a pharmaceutical manufacturing environment.

• Familiarity with audit procedures and regulatory inspections.

• Attention to detail with strong analytical and problem-solving skills.

• Proficiency in documentation, record-keeping, and compliance monitoring.

Why Join Us?

Opportunity to work with a dynamic and supportive team.

Exposure to diverse technical challenges and growth opportunities.

Competitive salary package and professional growth prospects.

To Apply: Send your updated resume to

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