Job Title: IPQA Officer
Job Summary:
An IPQA (In-Process Quality Assurance) Officer ensures compliance with quality standards and regulations during the manufacturing process. This role involves monitoring, verifying, and validating the production processes to ensure the final products meet the required specifications.
Key Responsibilities:
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Process Monitoring and Control:
- Continuously monitor production processes to ensure compliance with standard operating procedures (SOPs) and quality standards.
- Perform regular in-process checks and audits to identify any deviations from established protocols.
- Review batch production records (BPR) and ensure documentation accuracy and completeness.
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Quality Assurance Activities:
- Conduct inspections and testing of raw materials, in-process materials, and finished products.
- Validate and verify the accuracy and precision of analytical testing methods.
- Ensure proper calibration and maintenance of quality control equipment.
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Documentation and Reporting:
- Prepare and maintain detailed reports on quality assurance activities and findings.
- Document non-conformances, deviations, and corrective actions taken.
- Assist in the preparation and review of quality assurance documentation, including SOPs, validation protocols, and quality manuals.
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Compliance and Regulation:
- Ensure compliance with GMP (Good Manufacturing Practices), regulatory requirements, and company policies.
- Participate in internal and external audits, providing necessary documentation and support.
- Stay updated with changes in regulations and quality standards relevant to the industry.
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Problem Identification and Resolution:
- Identify and investigate quality-related issues, root causes, and potential risks.
- Implement corrective and preventive actions (CAPA) to resolve quality issues and prevent recurrence.
- Collaborate with cross-functional teams to address and resolve quality concerns.
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Training and Development:
- Provide training and guidance to production staff on quality assurance procedures and best practices.
- Promote a culture of continuous improvement and quality awareness within the organization.
Qualifications:
- Bachelor's degree in Pharmacy, Chemistry, Biotechnology, or a related field.
- Proven experience in quality assurance or quality control within the pharmaceutical, biotechnology, or related industry.
- Strong knowledge of GMP, regulatory standards, and quality assurance principles.
- Excellent analytical, problem-solving, and decision-making skills.
- Attention to detail and ability to work independently and as part of a team.
- Proficient in using quality management software and tools.
- Strong communication and interpersonal skills.
Working Conditions:
- Work in a manufacturing or laboratory environment.
- Regular interaction with production staff and cross-functional teams.
- May require occasional travel for audits and training.
Key Competencies:
- Detail-oriented with a focus on accuracy.
- Strong organizational and time-management skills.
- Ability to handle multiple tasks and meet deadlines.
- Commitment to continuous improvement and professional development.
This role is critical in maintaining the high standards of product quality and safety, ensuring that the company consistently delivers products that meet or exceed customer expectations.
Job Type: Full-time
Pay: From 120,
- 00 per year
Benefits: - Health insurance
* Leave encashment
Schedule:
Supplemental pay types:
Education:
Experience:
- total work: 1 year (Preferred)
Work Location: In person
