Key Responsibilities:

1. Stability Study Design & Planning

- Define study protocols, including time points, conditions (temperature, humidity, light exposure), and container types.
- Collaborate with formulation scientists and regulatory affairs teams to ensure studies align with regulatory guidelines (e.g., ICH, FDA).
- Plan long-term and accelerated stability testing for recent and existing products

2. Compliance & Documentation

- Document study protocols, deviations, results, and reports.
- Maintain comprehensive stability study records for internal reference and regulatory submissions.
- Prepare stability data for inclusion in regulatory filings, ensuring compliance with ICH, FDA, or other relevant guidelines.
- Ensure that all documents are stored according to GMP and are easily retrievable during audits.

3. Equipment & Process Management

- Well-versed with Chromeleon Software
- Performing a Dissolution Test
- Well-versed with QC lab Instruments

4. Cross-functional Coordination





- Work closely with Production, QA, Engineering, and Warehouse teams to ensure smooth operations.
- Support QMS activities

5. Safety & Hygiene Compliance

- Ensure adherence to aseptic techniques and environmental monitoring standards in cleanrooms.
- Follow safety protocols for handling hazardous chemicals and sterilization processes.
- Train production staff on GMP, hygiene, and workplace safety standards.

Required Qualifications & Skills:

- Education: B.Pharm / M.Pharm / M.Sc
- Experience: 2-7 years of experience in QC Stability Section for Formulation (preferably injectables)
- Technical Skills:
- Well-versed with Chameleon Software
- Performing a Dissolution Test
- Familiarity with cGMP, USFDA, EU-GMP, and WHO-GMP guidelines.
- Soft Skills: Strong problem-solving abilities, teamwork, attention to detail, and adaptability.

📌 Quality Control (Ahmedabad)
🏢 Spectrum Talent Management
📍 Ahmedabad