(Senior) Quality and Compliance Specialist

Main Duty:

1. Ensure the timely review of batch records, SOPs, investigations, corrective actions, change controls, technical documents, and the adherence to Quality Agreements.

2. Establish meaningful goals and metrics for groups in conjunction with the Function Lead, and manage the performance to those goals.

3. Ensure that all work is performed safely, with quality, and in a timely, compliant manner.

4. Manage and/or participate in the investigation of non-conformances and follow-up corrective/preventative actions in compliance with quality procedures, policies, and regulations. Ensure the group is doing the same as required.

5. GMP Compliance Oversight:

Oversee the GMP Vendor Audit Schedule. Ensure vendor and auditor availability (internal/external/consultant), and confirm audit dates with both auditors and vendors.

Review supplier audit reports, ensuring they meet Lotus QA standards and are compliant with Lotus SOPs.

Request documented evidence of closure when necessary, and file both electronically and in hard copy.

Review vendor audit responses and manage the review/editing cycle until responses are acceptable.

Submit observation reports to vendors, communicate response timelines, and track them to ensure timely responses.

Submit observation reports to customers/regulatory bodies, communicate response timelines, and track to ensure timely responses.

Ensure regulatory compliance from both dossier and site operation perspectives.

6. Quality Assurance Management:

Documentation control (e.g., master batch record, specification, and method)

Investigations, complaints, deviations, CAPAs, APRs