Here's a job description for a Quality Assurance and Regulatory Officer in a pharma company:
*Job Title:* Quality Assurance and Regulatory Officer
*Reports to:* Quality Assurance Manager/Head of Quality
*Job Summary:*
The Quality Assurance and Regulatory Officer is responsible for ensuring compliance with regulatory requirements, industry standards, and company policies in the manufacturing, testing, and distribution of pharmaceutical products. This role involves implementing and maintaining quality assurance systems, conducting audits and inspections, and collaborating with cross-functional teams to ensure product quality and regulatory compliance.
*Key Responsibilities:*
1. *Regulatory Compliance:*
- Ensure compliance with regulatory requirements, such as cGMP, ICH, and local regulations.
- Stay up-to-date with changes in regulatory requirements and implement necessary changes.
2. *Quality Assurance:*
- Implement and maintain quality assurance systems, including SOPs, policies, and procedures.
- Conduct audits and inspections to ensure compliance with quality standards.
- Identify and address deviations, CAPAs, and change controls.
3. *Documentation and Record-Keeping:*
- Maintain accurate and complete documentation, including batch records, SOPs, and training records.
- Ensure compliance with documentation and record-keeping requirements.
4. *Training and Awareness:*
- Provide training on quality assurance and regulatory compliance to production, quality control, and other relevant staff.
- Ensure awareness of regulatory requirements and quality standards.
5. *Collaboration and Communication:*
- Collaborate with cross-functional teams, including production, quality control, and regulatory affairs.
- Communicate effectively with stakeholders, including regulatory agencies, customers, and suppliers.
6. *Continuous Improvement:*
- Identify opportunities for continuous improvement and implement changes to enhance quality and efficiency.
*Requirements:*
1. *Education:* Bachelor's degree in Pharmacy, Life Sciences, or a related field.
2. *Experience:* Minimum 2-3 years of experience in quality assurance or regulatory affairs in the pharmaceutical industry.
3. *Skills:*
- Strong knowledge of regulatory requirements and industry standards.
- Excellent communication and interpersonal skills.
- Ability to work independently and as part of a team.
- Attention to detail and analytical skills.
*Certifications:*
1. *Quality Assurance Certifications:* Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE) certifications are desirable.
2. *Regulatory Certifications:* Knowledge of regulatory requirements and certifications, such as ISO 13485 or ISO 9001, is an advantage.
This role requires a detail-oriented and analytical individual who can ensure compliance with regulatory requirements and quality standards while collaborating with cross-functional teams to drive continuous improvement.