Overview:
The IPQA Chemist plays a crucial role in the Quality Assurance department ensuring that all inprocess materials and finished products meet quality standards and regulatory requirements. This role is vital in maintaining product quality compliance and the overall success of the organization.
Key Responsibilities:
- Perform inprocess quality checks and inspections.
- Conduct analytical testing of raw materials intermediates and finished products.
- Review and approve batch records SOPs and other documentation.
- Investigate deviations nonconformances and customer complaints.
- Collaborate with crossfunctional teams to resolve quality issues.
- Participate in internal and external audits.
- Provide support during regulatory inspections.
- Conduct stability testing and studies.
- Perform equipment qualifications and validations.
- Contribute to continuous improvement initiatives.
- Ensure compliance with GMP regulations and company policies.
- Assist in training and mentoring junior staff.
- Participate in risk assessments and quality risk management activities.
- Manage and maintain quality documentation and records.
- Conduct environmental monitoring and control activities.
Required Qualifications:
- Bachelors degree in Chemistry Pharmacy or related field.
- 2 years of experience in pharmaceutical quality assurance or related industry.
- Strong knowledge of cGMP regulations and guidelines.
- Proficiency in analytical techniques and instrumentation.
- Experience with deviation and CAPA management.
- Excellent attention to detail and accuracy.
- Ability to interpret and apply regulatory requirements.
- Effective communication and teamwork skills.
- Capability to prioritize and manage multiple tasks.
- Problemsolving and root cause analysis abilities.
- Experience with quality management systems.
- Familiarity with validation and qualification processes.
- Proficient in MS Office and qualityrelated software.
- Strong understanding of statistical analysis and quality control tools.
- Commitment to upholding ethical and professional standards.
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