Manufacturing Operations / Validation Manager

The Manufacturing Operations / Validation Manager at IBA InfoTech is responsible for ensuring that all manufacturing, packaging, and labeling processes comply with legal standards. Key duties include overseeing equipment and process validation, leading equipment qualifications, and ensuring processes adhere to FDA 21 CFR Part 820 and ISO 13485 guidelines.

To qualify for the Manufacturing Operations / Validation Manager position at IBA InfoTech, applicants should possess a bachelor's degree in Engineering, Manufacturing, Life Sciences, or a related field, along with 5-10 years of experience in quality and regulatory environments. Experience in regulated industries such as pharmaceuticals or medical devices is preferred.

Candidates for the Manufacturing Operations / Validation Manager role at IBA InfoTech should have a minimum of 5-10 years of experience in quality or regulatory environments, along with 3-8 years of leadership experience. Familiarity with regulated industries, such as pharma and food production, is crucial.

The Manufacturing Operations / Validation Manager significantly contributes to compliance at IBA InfoTech by leading efforts in equipment and process validation and ensuring processes are validated according to regulatory guidelines. This role also involves maintaining documentation and collaborating with Quality Assurance for QMS alignment.

Key skills for the Manufacturing Operations / Validation Manager at IBA InfoTech include strong leadership abilities, expertise in quality management systems, and in-depth knowledge of FDA regulations and ISO standards. Effective training and communication skills are also essential for mentoring team members.

In your response, highlight specific examples of equipment qualification projects you've led, focusing on the qualification process (IQ, OQ, PQ) and the outcomes achieved, demonstrating your hands-on experience and understanding of compliance.

When answering, detail the process you followed to create the validation plan, including stakeholder engagement and timeline management, and present how it ultimately improved manufacturing processes or compliance.

Share your strategies for training and developing your team on regulatory standards, such as ongoing workshops or updates on industry regulations, emphasizing the importance of keeping compliance at the forefront of operations.

Discuss your problem-solving process, detailing how you assess the issue, involve relevant stakeholders, and use CAPA methods effectively to resolve it, ensuring continuous improvement in validation processes.

Explain your approach to maintaining detailed and accurate validation documentation, emphasizing your commitment to compliance and thoroughness in record-keeping, and how it contributes to audit readiness.

In your answer, mention your direct interactions with regulatory bodies, any inspections you have been involved in, and how you ensured your operations met their guidelines.

Share examples of how you've successfully collaborated with other departments, such as Quality Assurance, and the impact it had on fostering a culture of compliance and teamwork in the organization.

List the software tools you've used, such as MES or ERP systems, and describe how these tools have enhanced your efficiency in validation or process management.

Discuss your mentoring style and strategies, emphasizing your focus on hands-on training, sharing best practices, and encouraging open communication to foster their growth in the validation field.

Craft your answer to reflect your passion for maintaining high compliance standards and your desire to work in a dynamic company like IBA InfoTech. Share your alignment with the company's mission and how your skills can contribute to its goals.