Quality Assurance (QA) Manager

Job Description

Job Description

Quality Assurance (QA) Manager

About Invatech :

Invatech is a leading pharmaceutical company with a rich history of innovation and a strong commitment to delivering high-quality products that improve patient lives.

Our mission is to maintain the highest standards of quality, compliance, and customer satisfaction. We value integrity, excellence, and teamwork, and we strive to create a supportive and inclusive work environment for our employees.

Key Responsibilities :

1. Develop, establish, and maintain quality assurance programs, policies, processes, procedures, and controls to ensure that products conform to established company, international (ISO), and governmental regulatory standards and agency guidelines.

2. Review and approve all master documents impacting the identity, strength, quality, and purity of drug products before use or subsequent change.

3. Ensure that validation protocols / summaries are reviewed and approved by the Quality Assurance unit to demonstrate that products, processes, equipment, and facilities consistently perform as required.

4. Investigate and address any unexplained deviations or discrepancies in drug product manufacturing, ensuring appropriate conclusions and follow-up for adequate Corrective and Preventive Actions (CAPA).

5. Review and oversee training within various operational areas to ensure that personnel engaged in GMP functions have adequate education, experience, and / or training.

6. Interface directly with representatives of various regulatory agencies and / or clients.

7. Interact with regulators and industry peers to maintain cGMP compliance.

8. Assist Regulatory Affairs with compliance requirements.

9. Review and approve laboratory failure investigations, laboratory deviations, and Quality Control documents (raw data).

10. Review and approve Batch Final Release for distribution.

11. Determine whether quality activities and related production and QC results comply with cGMP requirements.

12. Implement and manage systems to audit and evaluate policies, procedures, and practices impacting the company's cGMP operations.

13. Coordinate the preparation of technical documents and evaluate deficiencies and issues related to regulatory approval applications.

14. Function as an escort / contact for federal, state, or other external Regulatory Agencies during compliance reviews.

Qualifications :

• At least 10 years of experience as a Supervisor or above in a pharmaceutical or related industry
• Strong knowledge of cGMP regulations, ISO standards, and regulatory requirements
• Proven experience in developing and implementing quality assurance programs and policies
• Excellent communication, leadership, and problem-solving skills
• Ability to interface effectively with regulatory agencies and industry peers
• Bachelor's degree in a relevant field (e.g., Pharmacy, Chemistry, Life Sciences) or equivalent experience

Preferred Qualifications :

• Experience with FDA and EMA regulations
• ASQ Certified Quality Auditor (CQA) or Certified Manager of Quality / Organizational Excellence (CMQ / OE)
• Six Sigma Green Belt or Black Belt certification
• Expertise in risk management and quality by design (QbD)

Reporting to the Director of Quality, the Quality Assurance Manager will have the opportunity to make a significant impact on Invatech's quality culture and drive continuous improvement initiatives.

This position offers opportunities for career growth within our expanding organization.

This is a full-time position. We offer competitive wages as per industrial standards, along with a comprehensive benefits package.

If you are a highly motivated and experienced Quality Assurance professional with a passion for maintaining the highest standards of quality and compliance, we invite you to apply for this challenging and rewarding position.

Join our team and contribute to our mission of delivering innovative and life-changing pharmaceutical products.

Please submit your resume and cover letter to [email protected]

Invatech is an equal opportunity employer and values diversity in the workplace.