Quality Assurance/Control Chief - Mfg

Chief of Quality Assurance / Quality Control

Key duties/responsibilities:

- This position, a member of the senior management team, requires a well-organized, results-oriented individual who will focus on the all of the company’s compliance activities.

- The right candidate will be a knowledgeable and motivated professional with the experience and capability to actively recruit, train, manage and grow the company’s quality assurance, quality control and compliance capabilities to match the company’s overall growth.

- The chosen candidate will direct both the quality assurance and the quality control groups.

- This person must possess a strong cGMP background as well as strong communication skills with the ability to interact at a high level with both the company’s customers as well as the appropriate regulatory agencies when required.

- This individual must be able to interact and contribute along with the other members of the senior team.


Other Duties include:

- Assist executive management with the development of the quality plan.

- Performing and evaluation of cost and responsibility of discrepant material based on established methods and procedures.

- Quality management of the company’s products including developing and managing measurement systems, in-process manufacturing quality and machine capability.

- Developing corrective actions to support problems and failures, suggesting modifications and corrective actions.

- Maintain a quality assessment system to monitor quality objectives.

- Working on the Continuous Improvement Process through the application of quality tools and techniques.

- Troubleshooting both internal production line issues concerning components.

- Ensure that products and services meet expectations to fulfill quality objectives.

- Coordinates and approves all sample submissions of new product and engineering changes.

- Participates in new product design from beginning to end, insuring that manufacturing process capabilities match customer requirements.

- Create and sustain a culture that is based on continuous improvement.

- Administers and validates all engineering change notices.

- Material and final products to quality standards.

- Develops and maintains a supplier quality index, utilizing statistical control programs, to assure that only high-quality vendors are retained.

- Develops and implements a quality production program to ensure conformity of purchased material and final products to quality standards.

- Revises and updates the quality control manual.

- Take lead responsibility for significant quality issues. Be “hands on” with the issue, develop a plan to resolve the issue, communicate the plan and progress on the plan to the organization.

- Meets with quality representative and company personnel to discuss and resolve quality problems.

- Identify areas where product or service quality requires corrective action.

- When necessary, implement corrective action plans and monitor the effectiveness of the solutions.

- Conduct studies to determine cause, effect and the corrective measure required to remedy the deviation.

Other Requisites

- English speaking

- American University graduate

- American or European company work history

- Manufacturing in the pharma or supplement environment

- Currently living in India or has lived in India in the past

Job Specifications:

- The Chief of Quality Assurance and Quality Control will require an innovative individual who is willing to promote and/or lead the organization to develop a comprehensive Quality Assurance and Quality Control program that fully embraces the new compliance paradigm for dietary supplement.

- The appropriate candidate should have a scientific background, a science based degree or equivalent in a technical discipline and have a minimumof 10 yearsof experience in Quality Assurance/Quality Control and compliance.

- Experience in a cGMP environment in the dietary supplement or pharmaceutical (drug product) industry is required.

- B.S. or Master’s in Science or Engineering.

- Excellent communication skills. Proficient in English (Bilingual would be best)

- Additional formal education or training in Quality Assurance/Quality Control for manufacturing operation is preferred.

- 10 or more years of work experience in quality in a manufacturing environment.

- Prior management level accountability.

- Ability to champion planning and implementation of quality initiatives.

- Demonstrated ability to provide guidance and leadership in both quality methodology and quality systems.

- Detail oriented and self-motivated.

- Committed to the profession with a high sense of professional integrity

- Strong interpersonal, facilitation, and presentation skills.

- Demonstrated expertise and knowledge of cGMP’s, FDA regulations, SOP implementation, as well as an understanding of quality control principles and QA audit functions.

- Demonstrated excellent interpersonal, written, and verbal communication skills.

- Demonstrated decision-making ability and ability to positively influence/manage people.

- Demonstrated ability to work independently.

- Demonstrated experience conducting training classes, presentations, etc.

- Demonstrated knowledge of word processing software, preferably Microsoft Word.

- Demonstrated experience working with all levels in an organization.

Please send me your CV on mkorudu@antal.com