Hiring Alert: Quality Assurance – Sterile Formulations | Thane
Are you an experienced Quality Assurance professional with strong expertise in sterile pharmaceutical formulations? Here’s an exciting opportunity to take the next step in your QA career.
📍 Job Location
Thane, Maharashtra | Work From Office
💼 Experience Required
5+ years of relevant experience in Sterile QA
🔬 Key Responsibilities
The selected candidate will be responsible for ensuring robust quality systems and regulatory compliance across sterile manufacturing operations, including:
- Managing Quality Management System (QMS) activities, including Deviations, CAPA, OOS/OOT and Change Controls.
- Reviewing BPR/BMR and batch manufacturing records and ensuring timely release of sterile products.
- Managing QC specifications, analytical method validation and method transfer activities.
- Supporting Process Validation activities and ensuring compliance with approved protocols and procedures.
- Supporting regulatory and customer audits, supplier qualification and overall compliance activities.
- Ensuring adherence to MHRA and EU GMP requirements and maintaining a strong state of audit readiness.
🎯 Skills & Experience Required
Candidates should have:
- Hands-on experience in Sterile Formulations – Mandatory
- Strong knowledge of Sterile QA, QMS and Batch Review.
- Practical expertise in OOS/OOT, Deviations, CAPA and Change Controls.
- Good understanding of Process Validation.
- Strong analytical and documentation skills with excellent attention to detail.
- Ability to maintain consistent regulatory compliance and audit readiness.
🚀 Who Should Apply?
This opportunity is ideal for QA professionals who have substantial experience in sterile pharmaceutical manufacturing and are looking to contribute to a quality-driven organization while working with global GMP standards.
📩 How to Apply
Interested candidates can share their updated CV/profile at:
Know someone who fits this role? Share this opportunity with them!
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