Quality Specialist
TLDR
Strengthen end-to-end quality systems through skilled oversight in change control, documentation, GMP equipment qualification, and internal audit processes.
We’re seeking a seeking a detail‑oriented and compliance‑driven professional skilled in change control, documentation oversight, GMP equipment qualification, validation planning, investigations, and internal audit processes to strengthen end‑to‑end Quality systems.
Key Responsibilities:
- Responsible for processing and oversight of changes through the generation, justification, impact assessment, modification, review, approval, and implementation workflow. This includes but is not limited to SOPs, production records, test methods, specifications, protocols, reports, equipment, processes, material suppliers, facilities, computer systems etc.
- Responsible for processing of documents through the generation, modification, review, and approval workflow. This includes but is not limited to SOPs, production records, test methods, protocols, reports, labeling, etc. also, archival of records.
- Responsible for review/approval of all documentation associated with the establishment and configuration of GMP equipment including laboratory equipment. This includes any Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documents..
- Responsible for prepare the Validation Master Plan .
- Review of all documentation (i.e. LIR, OOS, Change Controls, etc.).
- Ensuring and performing investigation into a product quality complaint with resolution including corrective and preventive actions and closure of the investigation.
- Ensure Review, approval, and on time closure of the laboratory investigation / events with resolution including corrective and preventive actions along with effectiveness determination.
- Responsible for Performing, reporting of observations and verification of compliance reports of internal audit.
The ideal candidate will have:
Education: M.Sc. in Chemistry.
Experience: Minimum 3 to 5 years of industrial experience.
Preferred Industries: API / Pharma.
Make Your Mark with TAPI
Your journey with TAPI is more than a job—it’s an opportunity to make a lasting impact on global health. If you’re ready to lead, innovate, and inspire, we’re excited to welcome you to our team. Together, let’s shape the future of pharmaceuticals. Apply on top of this page and our talent acquisition team will be in touch soon!