Job Description

Drive and perform Audits (Internal/External / Supplier) in conformance with Organizations Global/Local QMS procedures & requirements. It includes: 

- Participate in the assessment of the audit needs

- Support the audit plan preparation and updates

- Distribute the annual audit schedule to auditees

- Collect and report performance metrics

- Participate in the audit process as per plan through close out

- Schedule, prepare and conduct the audit in collaboration with audit team as per plan

- Escalate the critical observations to management

- Prepare, approve and distribute the audit report

- Review the site CAPA plan for appropriateness

- Communicate agreement of the auditee CAPA plans.

- Follow-up CAPA plan until close out.

- Partner with local operational groups to foster a proactive approach to compliance

Promote the concept of quality, the principles of quality management and devise and implement quality improvements.

Oversee and maintain Supplier Qualification System under Supplier Qualification Program in compliance to Quality System Regulations, ISO standards, internal Quality System and other requirements.

Provide oversight and leadership in supplier selection, qualification, ongoing monitoring, management and improvement.

Develop Quality Agreements, specification and technology transfer to support Supplier Qualification activities.

Implement supplier process validation and verification practices in compliance with requirements; manage supplier change control; lead suppliers through risk management and process improvement activities.

Manage Supplier Corrective and Preventive Action including investigation, execution of remedial activities and improvement of supplier Quality Management Systems. 

Desired Profile

- An excellent knowledge of current GxP regulations, QMS guidelines (ISO 9001:2008/ ISO 13485 standard), and associated regulatory requirement. 

- Hands on Experience in performing audits as per ISO 19011 requirements.

- Schedule orientated (able to consistently maintains schedules and meet deadlines)

- Data Analysis, Objective thinking, judgment and leadership skills.

- Knowledge of word-processing, spreadsheet, and database applications. 

- Strong interpersonal skills, Effective organization, communication, team orientation, and leadership skills. 

- Ability to work independently with initiative

Education: UG -B.Tech/B.E. - Bio-Chemistry/Bio-Technology, Biomedical, B.Sc - Bio-Chemistry, Chemistry 

PG - M.Tech - Bio-Chemistry/Bio-Technology, Biomedical, M.Sc - Chemistry, Bio-Chemistry, Microbiology 

Doctorate - Doctorate Not Required

Company Profile

Alere Medical Pvt. Ltd. Alere is a major global developer, manufacturer and marketer of pioneering consumer and professional medical diagnostic products. By developing new capabilities in near-patient diagnosis, monitoring and health management, Alere enables individuals to take charge of improving their health and quality of life at home. We are looking for individuals with the expertise, passion, and drive to contribute to a team that"s committed to solving the big healthcare challenges that exist today and revolutionizing medical diagnosis. We offer a wide range of employment opportunities for scientists, engineers, chemists, laboratory technicians, and manufacturing workers, as well as individuals with backgrounds in marketing, finance, human resources, administrative support, and more. We invite you to explore Alere further to see for yourself why it's a great place to work.

Contact Details

Recruiter Name:      Mr. R. Baruah

Contact Company: Alere Medical Pvt Ltd

Telephone:                 01244130311