Overview: As a Quality Assurance Associate at [Company Name], you will play a key role in ensuring that our pharmaceutical products meet regulatory requirements and adhere to quality standards. You will work closely with cross-functional teams to implement and maintain quality systems and processes throughout the product lifecycle.

Key Responsibilities:

1. Conduct routine inspections and audits of manufacturing processes, facilities, and documentation to ensure compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant regulations.
2. Review batch records, production documents, and quality control test results to verify product quality and compliance with specifications.
3. Assist in the investigation of deviations, non-conformances, and customer complaints, and collaborate with relevant departments to implement corrective and preventive actions (CAPAs).
4. Participate in the review and approval of validation protocols, master batch records, and standard operating procedures (SOPs) to ensure accuracy and compliance with regulatory requirements.
5. Support internal and external audits by regulatory agencies or third-party auditors, and contribute to the development and implementation of audit responses and corrective actions.
6. Provide training to employees on quality procedures, regulations, and documentation requirements to promote a culture of quality and compliance.
7. Maintain documentation and records related to quality assurance activities, including batch records, inspection reports, and CAPA documentation, in accordance with company policies and regulatory guidelines.
8. Stay current with developments in regulations, guidelines, and industry best practices related to pharmaceutical quality assurance, and proactively recommend improvements to quality systems and processes.

Qualifications:

• Bachelor's degree in a scientific or engineering field, preferably in pharmacy, chemistry, biology, or related discipline.
• [Specify any required certifications or licenses, if applicable.]
• [Specify any required years of experience in pharmaceutical quality assurance or related field.]
• Strong knowledge of GMP, GLP, and other relevant regulatory requirements for pharmaceutical manufacturing.
• Excellent attention to detail and analytical skills, with the ability to interpret and apply complex regulations and guidelines.
• Effective communication and interpersonal skills, with the ability to collaborate across departments and communicate effectively with internal and external stakeholders.
• Ability to work independently and prioritize tasks in a fast-paced environment, while maintaining a focus on quality and compliance.
  
  Note: This job description is intended to convey information essential to understanding the scope of the position and is not exhaustive. Duties, responsibilities, and qualifications may be adjusted as needed to meet the evolving needs of the company.