Job Responsibilities :

Accountable for following activities of Contract Operations Quality:

• Well acquainted with QRM process and should able to independently perform the QRM assessment.

• Capable to handle multiple projects and well versed with project management skills

• Should have good communications, drafting and presentations skills.

• Well versed with Excel/ PowerPoint applications.

• Well versed with Schedule M/WHO/ D&C acts /cGMP/GLP/CDSCO guidance’s and should able to ensure compliance at TPM sites.

• Perform TPM site visits on scheduled basis to ensure continuous Quality compliance.

• Well versed with Pharmacopoeia changes and compliance.

• Should able to conduct investigation of the Market complaint, root cause analysis, CAPA implementation and its effectiveness check.

• Review, assessment and approval of change controls, deviations, OOS/Failures.

• To perform technical assessment of change control, audit CAPA tasks in QMS system.

• Should have ability to impart technical training to quality and operations staff.

• To perform assessment of new site for cGMP compliance as and when required.

• To carry out TPM performance monitoring by reviewing the metrics and score card as defined in the procedure.

Minimum Education

B.Sc / M.Sc /B.Pharm / M.Pharm

Minimum Experience / Training Required :

At least 10 – 15 years of relevant experience in quality assurance function either at internal sites / third party manufacturers. Incumbent having expertise in Quality Risk Management, Quality Project Management will be an preferred.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com