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Abbott QA Jobs For BS Biology – Apply Online
Assistant Manager Quality Assurance
Location: India > Village Mauza: Baddi
Category: Quality
Job Summary
The cGMP Audit and Compliance Manager is responsible for overseeing and managing the company’s compliance with cGMP regulations, conducting internal and external audits, and ensuring that all manufacturing processes meet regulatory standards.
Key Responsibilities
- Develop and Implement Compliance Programs: Create and maintain compliance programs to ensure adherence to cGMP and other regulatory requirements.
- Conduct Audits: Perform regular internal and external audits to identify compliance issues and areas for improvement.
- Training and Education: Provide training to employees on cGMP standards and regulatory requirements.
- Documentation and Reporting: Maintain accurate records of compliance activities and prepare reports for senior management and regulatory bodies.
- Risk Management: Identify potential compliance risks and develop strategies to mitigate them.
- Policy Development: Develop and update company policies and procedures to ensure ongoing compliance with regulatory standards.
- Collaboration: Work closely with other departments, such as Quality Assurance, Legal, and Operations, to ensure a cohesive approach to compliance.
Qualifications
- Education:
- Bachelor’s degree in Pharmacy, Chemistry, Biology, or a related field.
- Advanced degrees or certifications in regulatory affairs or compliance are a plus.
- Experience: Proven experience in a compliance or quality assurance role within the pharmaceutical industry.
- Knowledge: In-depth understanding of cGMP regulations and other relevant regulatory requirements.
- Skills: Strong analytical, communication, and organizational skills. Ability to work under pressure and manage multiple tasks simultaneously.
Additional Information
- Work Environment: Office setting with potential travel to manufacturing sites and regulatory meetings.
- Reporting Structure: Typically reports to the Director of Compliance or Quality Assurance.
Core Job Responsibilities
- Review and approve proposals, impact assessments, and quality risk assessments for change control and planned deviation.
- Coordinate, review, and approve all change control records and related tasks in Trackwise.
- Initiate, review, approve, and implement quality improvement projects.
- Review and approve master documents, including site SOPs, APQRs, specifications, STPs, GTPs, general protocols and reports, and training materials.
- Review and approve the Annual Product Quality Review within the defined timelines.
- Identify improvement areas or recommendations through the Annual Product Quality Review.
- Coordinate with the site inspection administrator in conducting external audits, internal AQR audits, regional audits, and divisional audits. Ensure the timely submission of communication forms to EPD Inspection Administrator.
- Facilitate the audit-related investigation process. Track and monitor CAPAs related to audits investigation.
- Ensure audit compliance responses for external, internal AQR, divisional, and regional audits are submitted within the stipulated timeline.
- Ensure regulatory updates are done as per approved site procedures.
- Ensure the effective implementation and compliance of the Quality Management System.
- Keep track of self-training through ISOTRAIN and ensure timely completion of training within the stipulated timeline. Maintain self-training records.
- Perform all miscellaneous activities as assigned by seniors.
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