Regulatory Compliance Specialist
4 days ago
Job Summary:
As a Regulatory Compliance Specialist at SUN PHARMA, you will be responsible for ensuring that all manufacturing processes and procedures meet the required regulatory standards. This includes preparing and reviewing new product documents, tracking and evaluating product history and process parameters, and submitting investigation reports for OOS, OOT, and any failures. You will also participate in various regulatory audits to support the plant.
Key Responsibilities:
- Preparing and reviewing new product documents: Material requirement sheet, master formula card, bill of material, master formula, risk assessment reports, sampling protocol, reports, exhibit batch manufacturing record, and exhibit protocols and reports.
- Tracking and evaluating product history and process parameters: Review and evaluate product history and process parameters for technical remediation and improvement of product robustness.
- Submitting investigation reports: Prepare and submit investigation reports for OOS, OOT, and any failures for exhibit/validation/commercial batch manufacturing and during stability testing.
- Participating in regulatory audits: Participate in various regulatory audits to support the plant.
Requirements:
- Education: Bachelor's degree in a relevant field.
- Experience: 2+ years of experience in a similar role.
- Skills: Strong knowledge of regulatory requirements, excellent communication and problem-solving skills.
What We Offer:
- Competitive salary and benefits: SUN PHARMA offers a competitive salary and benefits package.
- Opportunities for growth and development: We offer opportunities for growth and development in a dynamic and fast-paced environment.
- Collaborative team environment: Our team is collaborative and supportive, with a focus on teamwork and open communication.
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