We are seeking an experienced and detail-oriented Quality Assurance Manager to join our team. The successful candidate will be responsible for overseeing the quality control processes within our pharmaceutical manufacturing facility, ensuring compliance with Good Manufacturing Practices (GMP) and maintaining the highest standards of product quality.
Key Responsibilities:
- Quality Management: Overseeing and managing the quality management system (QMS) to ensure compliance with industry standards, regulations, and internal quality control procedures.
- Regulatory Compliance: Staying up to date with pharmaceutical regulations, guidelines, and standards (e.g., FDA, EMA) and ensuring the facility's operations are compliant. Working closely with Apozeal leadership, propose and implement the best strategy to expedite cGMP compliance to start production, packaging, and distribution of Apozeal products acquired from Torrent Pharma. Responsible to address Health authority (FDA) inquires regarding Apozeal facilities and products, manage all regulatory notifications as necessary and host FDA audits as necessary.
- Quality Audits: Conducting internal and external quality audits to identify non-compliance issues and implementing corrective and preventive actions (CAPA) as needed.
- Quality Documentation: Managing and maintaining all quality-related documentation, including SOPs, batch records, and validation documentation.
- Product Release: Authorizing the release of finished pharmaceutical products after confirming they meet all quality and regulatory requirements.
- Change Control: Evaluating and approving proposed changes to processes, equipment, and materials to ensure that changes do not impact product quality or safety.
- Risk Assessment: Identifying and assessing potential risks to product quality and developing risk mitigation plans.
- Training and Development: Providing training to staff on quality control and assurance procedures and regulatory requirements to ensure consistent compliance.
- Supplier Quality Management: Collaborating with suppliers and conducting quality assessments to ensure that raw materials and components meet quality standards.
- Data Integrity: Ensuring data integrity in all quality-related processes, documentation, and records.
- GMP (Good Manufacturing Practices): Ensuring the facility's compliance with GMP standards and guidelines.
- Sustainability and Environmental Responsibility: Promoting environmentally responsible practices and sustainability in the pharmaceutical manufacturing processes.
Qualifications:
- Minimum of 5 years of experience in quality control, preferably in a pharmaceutical manufacturing environment.
- Proven expertise in method development and validation.
- In-depth knowledge of GMP regulations and requirements.
- Excellent analytical and problem-solving skills.
- Strong leadership and team management abilities.
- Effective communication and interpersonal skills.
- Detail-oriented with a strong commitment to quality.
Join our team and enjoy competitive pay, opportunities for growth, and a dynamic work environment. If you possess the required skills and are ready to contribute to our manufacturing operations, we encourage you to apply.
Job Type: Full-time
Pay: $150,000.00 - $160,000.00 per year
Work Location: In person