Are you an experienced quality assurance professional passionate about ensuring pharmaceutical excellence? Sanolet Lifecare Pvt Ltd, a leading manufacturer of dry powder injections including beta-lactam, cephalosporins, and veterinary injections, is hiring a Quality Assurance Manager in Ahmedabad, Gujarat. This is a full-time, on-site role offering a dynamic opportunity to lead quality assurance processes, ensure compliance with global standards, and contribute to innovative pharmaceutical production. If you thrive in a fast-paced environment and have expertise in cGMP, FDA, and WHO regulations, this role is for you!
Responsibilities
As a Quality Assurance Manager at Sanolet Lifecare, you will play a pivotal role in maintaining the highest standards of quality for pharmaceutical products. Your key responsibilities include:
- Overseeing facility, equipment, and process qualification, including User Requirement Specifications (URS), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Ensuring compliance with Current Good Manufacturing Practices (cGMP), FDA, and WHO standards.
- Approving validation protocols and reports for cleanrooms, HVAC systems, sterilizers, filling lines, and lyophilizers.
- Monitoring aseptic process simulations (media fills) and ensuring sterility assurance.
- Managing the Validation Master Plan (VMP), deviations, Corrective and Preventive Actions (CAPAs), and change control processes.
- Ensuring container-closure integrity, cleaning validation, and powder filling accuracy.
- Leading cross-functional teams and providing GMP and aseptic processing training.
- Supporting regulatory inspections with comprehensive qualification documentation.
Qualifications
To succeed in this role, you should have the following qualifications:
- Bachelor’s or Master’s degree in Pharmacy, Chemistry, or a related field.
- 5+ years of experience in pharmaceutical quality assurance, preferably in dry powder injections or aseptic processing.
- In-depth knowledge of cGMP, FDA, and WHO regulations.
- Expertise in validation protocols (URS, DQ, IQ, OQ, PQ) and aseptic process simulations.
- Strong leadership skills to manage QA teams and collaborate cross-functionally.
- Proficiency in managing deviations, CAPAs, and change control processes.
- Excellent communication and documentation skills.
- Experience with regulatory inspections is a plus.
Benefits
Joining Sanolet Lifecare offers a rewarding career with the following benefits:
- Competitive salary range of INR 8,00,000–12,00,000 per annum, based on experience.
- Opportunities for professional growth in a leading pharmaceutical company.
- Collaborative and innovative work environment.
- Comprehensive health and wellness benefits.
- Support for continuous learning and certifications in quality assurance.
Application Instructions
Ready to take the next step in your career? To apply for the Quality Assurance Manager position at Sanolet Lifecare, please submit your resume and a cover letter detailing your relevant experience to careers@sanoletlifecare.com. Ensure your application highlights your expertise in pharmaceutical quality assurance and compliance. Applications will be reviewed on a rolling basis, with a deadline of October 30, 2025. Don’t miss this opportunity to join a leader in pharmaceutical manufacturing!
FAQs
What qualifications are required for the Quality Assurance Manager role?
Candidates should have a Bachelor’s or Master’s degree in Pharmacy, Chemistry, or a related field, along with 5+ years of experience in pharmaceutical quality assurance, strong knowledge of cGMP, FDA, and WHO regulations, and expertise in validation protocols.
What is the salary range for this position?
The salary for the Quality Assurance Manager role at Sanolet Lifecare ranges from INR 8,00,000 to INR 12,00,000 per annum, depending on experience and qualifications.
