Quality Specialist - II

Summary

The Specialist, Quality Assurance plays a crucial role in ensuring compliance with GMP regulations and supporting quality assurance activities in a pharmaceutical manufacturing environment. This role is responsible for batch record management, document retrieval and generation, batch record review, product release, and supporting site quality investigations. The ideal candidate will have strong leadership capabilities, critical thinking skills, and the ability to work independently while meeting production and compliance demands.

Responsibilities

• Retrieve, track, and archive site batch records, ensuring proper document retention.
• Manage storage, retrieval, and destruction of batch records beyond the retention period.
• Ensure proper allocation of Document Retention room capacity.
• Assist with the reconciliation of controlled print documents.
• Prepare and provide Certificates of Compliance (CoC) for finished goods batches and support Certificate of Analysis (CoA) requests.
• Track and process Registered Country Table (RCT) tender request forms for batch allocation in the SAP system.
• Perform batch record reviews and intermediate/finished product release activities for domestic distribution.
• Conduct Quality Assurance review and approval of GMP-related SOPs and assist in compliance improvement initiatives.
• Support defect resolution, statistical analysis, and material control within the plant site.
• Participate in plant investigation root cause analysis, corrective action identification, and material disposition recommendations.
• Own and complete Quality-related investigations.
• Engage in project and PCR strategy meetings for Quality Master Data builds and maintenance.
• Support the implementation of new programs, regulations, and divisional processes at the site.
• Identify and implement continuous improvement opportunities for business and compliance excellence.
• Maintain 5S organization and identify process improvement opportunities.
• Demonstrate leadership by promoting workplace safety and proactive risk mitigation.

Education

• B.A./B.S. degree (preferably in Science or Engineering).

Experience & Skills

• Minimum of three (3) years’ experience in a GMP pharmaceutical manufacturing facility, with direct or indirect involvement in Quality functions.
• Advanced proficiency in operating information systems, preferably SAP and Veeva.
• Strong written and oral communication skills, with the ability to work effectively in a team.
• High attention to detail, problem-solving abilities, and time management skills.
• Ability to analyze problems, assess solutions, and apply standard procedures.
• Ability to work under pressure, multitask, and meet project timelines.
• Experience in responding to data requests and proactively utilizing data for process improvement.