Quality Control
- Intas
- 3 - 8 years
- Ahmedabad
- 9 days ago
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Job Description
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.
Preferred Experience:
- Experience in an injectable/sterile manufacturing in QC Stability
- Exposure to regulatory inspections and audits.
- Knowledge of GLP and GDP
Benefits:
1. Mediclaim
2. Term Life Plan
3. Accidental insurance
4. Free transportation across city
5. Relocation Allowances
If interested, share your updated resume on pa*************t@st**l.co.in
Job Classification
Industry: Pharmaceutical & Life SciencesFunctional Area / Department: Quality AssuranceRole Category: Production & ManufacturingRole: QA / QC AnalystEmployement Type: Full timeContact Details:
Company: IntasLocation(s): Ahmedabad+ View Contact
Keyskills: HPLC Hplc Analysis Karl Fischer Calibration GC Dissolution
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