Sr. Quality Associate - Engineering Compliance

6 - 10 years

0 Lacs

karnataka

Posted:1 week ago| Platform: Shine logo

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Skills Required

calibration pm breakdown maintenance utility operation surveillance compliance sops deviations capa qrm documentation check maintenance of equipment building infrastructure workorder review quality perspective calibration certificates preventive maintenance checklists calibration procedures it procedures qms elements change controls audit commitments

Work Mode

On-site

Job Type

Full Time

Job Description

As an experienced Engineer in the Biopharma industry, your role will involve the following responsibilities: - Reviewing engineering activities such as calibration, PM, breakdown maintenance, and utility operation to ensure compliance with written procedures for equipment and building infrastructure. - Participating in routine equipment breakdown workorder review meetings, assessing workorder reports for quality, and ensuring timely closure of workorders. - Supporting the annual review of equipment breakdowns and participating in remediation programs. - Reviewing calibration certificates of instruments and participating in calibration activities on the shopfloor. - Reviewing engineering design documents for equipment and utilities as a Subject Matter Expert (SME). - Reviewing SOPs, Preventive Maintenance checklists, calibration procedures, and IT procedures implemented at the site. - Providing support to the Engineering and IT departments by tracking, drafting, reviewing, and closing documents related to QMS elements like Deviations, Change Controls, CAPA, QRM, and audit commitments. Qualifications required for this role include: - BE/B.Tech degree with specialization in Mechanical or EEE - B. Pharm qualification You should have more than 6-8 years of experience, preferably in the Biopharma industry.,

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Kemwell Biopharma

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