Quality Control

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 new 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.