Hiring: QA Executive / Assistant Manager QA at Bioaltas
Position: QA Executive / Assistant Manager QA
Company: Bioaltus Laboratories Pvt. Ltd.
Location: MIDC Paithan, Chhatrapati Sambhaji Nagar, Maharashtra
Industry: API Manufacturing
Role Overview:
We are looking for a dynamic Quality Assurance professional to join our team at the Paithan manufacturing facility. The ideal candidate will have strong expertise in API validation, QMS documentation, and regulatory compliance.
Key Responsibilities:
Validation & Qualification: Lead and manage expertise in process validation, cleaning validation, equipment qualification, and water system qualification/validation.
QMS Documentation: Handle end-to-end Quality Management System documentation, including change control, deviations, OOS (Out of Specification), incidents, and CAPA (Corrective and Preventive Actions).
Audit Management: Facilitate and handle customer and regulatory audits, ensuring compliance with WHO-GMP, USFDA, and EU-GMP standards.
Regulatory Submissions: Responsible for the preparation and submission of Drug Master Files (DMF).
Qualifications:
Education: B.Pharm / M.Pharm / M.Sc.
Experience: Relevant experience in API Quality Assurance (typically 3–10 years depending on the level).
How to Apply:
Interested candidates can share their updated CV via:
Email: qa@bioaltuslabs.com
WhatsApp: +91 7821822615
FAQ for Your Job Post
1) What is the location of the job?
The position is based at our API manufacturing unit in MIDC Paithan, Chhatrapati Sambhaji Nagar.
2) What regulatory standards must I be familiar with?
Candidates must have experience with WHO-GMP, USFDA, and EU-GMP audit standards.
3) What specific validation experience is required?
We are looking for expertise in process, cleaning, equipment, and water system qualification.
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