QA Executive – Bio Manufacturing | IPCA Labs | Pithampur

Job Description

• The quality Assurance specialist is responsible to support for overall Implementation and maintenance of the Quality Management System at Pithampur, Indore.
• Documentation Management (review, approval, maintenance of documents, and follow-up with SMEs).
• Review and Approval of all SOPs related to Ipca, Pithampur, Indore
• Review documents related to CMO.
• Provide training to QA and other departments as and when required.

Key Responsibilities:

• Track and carry out CMO activities for Tech transfer and ongoing batches,
• Responsible for continuous In-process Quality Audit at CMO Site for Ipca batches.
• Review of Batch Manufacturing Record for CMO site for Ipca.
• Review of Tech Transfer-related documents such as TTDs, MOAs, Specifications, AMTPs, and MQRs.
• Conduct an internal audit and audits at CMO.
• Participate in Vendor/consultant audits

Key Activities:

• Keeping track and issuance and Retrieval of Lab Note Book, Log Book, Record Book, Batch Process Record books, Key and Tank Book issuance.
• Archival of Service reports-Breakdown, Calibration Reports.
• Checking the compliance of SOPs and QA Visits in the Lab.

Qualification/Experience: BSc/MSc in Microbiology with 3 – 4 years of QA experience