14 Nov
|
vueverse.
|
India
We are looking for experienced Quality Investigation Specialists with solid pharmaceutical manufacturing experience, particularly in Solid Oral Dosage (OSD) forms.
The candidate should have hands-on expertise in investigating manufacturing deviations, quality incidents and product-related issues, identifying root causes and implementing effective CAPA.
Key Responsibilities
- Lead and perform investigations related to manufacturing deviations, non-conformances, OOS/OOT and quality incidents.
- Investigate issues associated with solid oral dosage forms, including tablets and capsules.
- Perform root cause analysis using methodologies such as 5 Why, Fishbone and other structured investigation techniques.
- Identify appropriate corrective and preventive actions (CAPA) and monitor their effectiveness.
- Investigate process-related issues involving granulation, blending, compression,
coating and packaging.
- Prepare and review investigation reports in compliance with GMP requirements.
- Collaborate with Manufacturing, Quality Control, Engineering and other cross-functional teams to close investigations within timelines.
Mandatory Requirements
- 5–12 years of experience in pharmaceutical Quality Assurance / Quality Investigations.
- Strong hands-on experience in deviation management, root cause analysis and CAPA.
- Direct experience with Solid Oral Dosage (OSD) manufacturing processes.
- Good understanding of GMP and pharmaceutical quality systems.
- Experience independently handling and documenting investigations.
📌 Quality Investigations Specialist – Solid Oral Dosage Forms (India)
🏢 vueverse.
📍 India