Job Summary:

We are seeking an experienced Quality Assurance Specialist to join our team in ensuring the highest quality standards in our pharmaceutical products. The successful candidate will be responsible for implementing and maintaining quality systems, conducting audits, and ensuring compliance with regulatory requirements.

Key Responsibilities:

- Implement and maintain quality systems, including GMP, GDP, and GLP

- Conduct internal audits and vendor audits to ensure compliance with regulatory requirements

- Develop and implement quality procedures and standards

- Collaborate with cross-functional teams to resolve quality issues

- Conduct quality risk assessments and implement mitigation strategies

- Ensure compliance with regulatory requirements, including FDA, EU, and WHO guidelines

- Develop and deliver quality training programs for employees

- Manage and maintain quality documentation and records

- Participate in continuous improvement initiatives to enhance quality systems

Requirements:

- Bachelor's degree in Pharmacy, Chemistry, Biology, or related field

- Minimum 3 years of experience in Quality Assurance in a pharmaceutical company

- Strong knowledge of GMP, GDP, and GLP regulations

- Excellent analytical and problem-solving skills

- Effective communication and interpersonal skills

- Ability to work in a fast-paced environment and prioritize tasks effectively

Nice to Have:

- Certification in Quality Assurance (e.g., CQA, CQE)

- Experience with quality management systems (e.g., ISO 9001)

• - Knowledge of regulatory affairs and compliance