Executive Quality Control
1 day ago
Job Description: Officer, Good Laboratory Practices (GLP) in Pharma Manufacturing
Position Overview:
As an Officer specializing in Good Laboratory Practices (GLP) within the pharmaceutical manufacturing sector, you will play a crucial role in ensuring that laboratory activities adhere to strict regulatory guidelines and industry standards. Your responsibilities will revolve around maintaining the quality and integrity of laboratory operations, processes, and data to support the manufacturing of pharmaceutical products.
Key Responsibilities:
- Compliance Assurance:
- Implement and enforce GLP guidelines, regulations, and standard operating procedures (SOPs) within the laboratory setting.
- Conduct regular audits and inspections to assess compliance with GLP requirements.
- Identify areas for improvement and recommend corrective actions to address non-compliance issues.
- Documentation Management:
- Oversee the creation, review, and maintenance of all laboratory-related documentation, including protocols, reports, and records.
- Ensure that documentation meets regulatory standards and is accurately completed in a timely manner.
- Develop and maintain a comprehensive documentation system for easy retrieval and reference.
- Training and Education:
- Provide training to laboratory personnel on GLP principles, procedures, and best practices.
- Conduct periodic training sessions to reinforce compliance awareness and update staff on regulatory changes.
- Keep abreast of new developments in GLP regulations and disseminate relevant information to the team.
- Quality Control:
- Collaborate with Quality Control (QC) teams to ensure that analytical methods and testing protocols comply with GLP standards.
- Monitor laboratory equipment and instruments to ensure proper calibration, maintenance, and performance validation.
- Participate in the investigation and resolution of laboratory deviations, out-of-specification results, and other quality issues.
- Data Integrity:
- Implement measures to safeguard the integrity, confidentiality, and accuracy of laboratory data.
- Review data generated in the laboratory for completeness, accuracy, and compliance with GLP requirements.
- Implement electronic data management systems to enhance data integrity and traceability.
- Continuous Improvement:
- Identify opportunities for process optimization and efficiency enhancements within the laboratory.
- Participate in cross-functional teams to implement quality improvement initiatives and address root causes of issues.
- Monitor key performance indicators (KPIs) to track the effectiveness of GLP implementation and drive continuous improvement efforts.
Qualifications:
- Bachelor's or Master's degree in a scientific discipline (e.g., Chemistry, Biology, Pharmacy, or related field).
- Strong understanding of Good Laboratory Practices (GLP) regulations and guidelines (e.g., FDA, EMA, ICH).
- Prior experience in a pharmaceutical manufacturing environment with a focus on GLP compliance preferred.
- Excellent attention to detail and organizational skills.
- Effective communication and interpersonal abilities.
- Proficiency in using laboratory equipment and computer systems.
**Job Types**: Full-time, Permanent
**Salary**: ₹12,000.00 - ₹20,000.00 per month
**Benefits**:
- Health insurance
- Life insurance
- Paid sick time
- Provident Fund
Schedule:
- Day shift
**Experience**:
- GLP total work: 2 years (required)
Ability to Commute:
- Panchkula, Haryana (required)
Ability to Relocate:
- Panchkula, Haryana: Relocate before starting work (required)
Work Location: In person
**Speak with the employer**
+91 7888979205
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