Ipqa Chemist

4 days ago

Nagpur Maharashtra, India NITIKA PHARMACEUTICAL PVT LTD Full time

Key Responsibilities:

- Perform in-process quality checks during various stages of pharmaceutical manufacturing processes to ensure compliance with standard operating procedures (SOPs), current Good Manufacturing Practices (cGMP), and regulatory guidelines.
- Conduct inspections and tests on raw materials, intermediates, and finished products to verify conformity to specifications and quality standards.
- Monitor and document manufacturing processes, including sampling, testing, and data analysis, to identify deviations, trends, and potential quality issues.
- Collaborate with production, quality control, and other departments to investigate and resolve quality-related discrepancies, non-conformances, and out-of-specification results.
- Participate in the development and revision of SOPs, validation protocols, and quality documentation to support continuous improvement initiatives.
- Maintain accurate records of all quality assurance activities, including test results, deviations, corrective actions, and change controls, in compliance with regulatory requirements.
- Assist in the qualification and validation of equipment, processes, and analytical methods, as needed.
- Provide training and guidance to manufacturing personnel on quality procedures, protocols, and best practices.
- Support internal and external audits, inspections, and regulatory filings by preparing documentation and responding to inquiries related to in-process quality assurance.
- Stay informed about industry trends, regulatory updates, and best practices in pharmaceutical quality assurance to ensure compliance and drive continuous improvement.

Qualifications:

- Bachelor's degree in Chemistry, Pharmaceutical Sciences, or related field. Master's degree preferred.
- Freshers/Maximum 2 years of experience in pharmaceutical manufacturing or quality control, with specific experience in in-process quality assurance.
- Strong understanding of cGMP regulations, FDA guidelines, and international quality standards (e.g., ICH, USP).
- Proficiency in analytical techniques, such as HPLC, GC, UV-Vis spectroscopy, and wet chemistry methods.
- Excellent analytical, problem-solving, and decision-making skills.
- Effective communication and interpersonal abilities, with the capability to work collaboratively in a cross-functional team environment.
- Detail-oriented mindset with a commitment to accuracy and compliance.
- Ability to prioritize tasks, manage multiple projects simultaneously, and meet deadlines in a fast-paced, dynamic environment.
- Familiarity with quality management systems (e.g., Track Wise, SAP) and electronic document control systems is desirable.

Pay: ₹10,000.00 - ₹20,000.00 per month

Schedule:

- Day shift
- Morning shift
- Night shift
- Rotational shift

**Education**:

- Bachelor's (preferred)

Work Location: In person

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