JOB DESCRIPTION

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.

JOB DUTIES/ RESPONSIBILITIES/ ACCOUNTABILITIES:

• Person should have  good experience  in  Pharmaceutical  Quality assurance from the reputed organisations  handled  multiple  dosage forms. Also he/she should well conversant with GxP , Schedule M and ICH requirements. 
• Person should be well versed and good exposure with quality management system, risk assessments, Investigations, CAPA and compliance and to lead team effectively.
• Working experience  to Injectable products will be added advantage.
• Good in written and verbal  communications along with stakeholder management .
• Responsible for the oversight of Quality operations and GMP compliance of  TPM’s of Contract Operations in India. 
• Responsible for coordination between Abbott quality management and site quality management and will Implement Quality Projects at identified TPM’s from time to time .
• Ensure quality compliance to regulatory w.r.t. labelling, stability studies and documentation  to deliver acceptable quality products from TPM sites to consumers.
• To lead  onsite investigation of market complaints along with site team for actual root cause analysis and monitoring of effectiveness of action plan along with timely closure .
• Shall be accountable for effectiveness of Abbott SOPs and quality technical agreement at contract manufacturing sites. To escalate the concern timely to Abbott management.
• To identify training needs of sites and team members  based on day to day observations and provide  trainings to them.
• To review OOS, deviation, incident & change control of Abbott products and to ensure comprehensive investigation. Tracking and closure of identified CAPA to be done effectively.
• To ensure and lead Pharmacopeial changes effectively for Abbott products in timely manner.
• Ensure that the associated TPM’s are maintained in a state of Quality and compliance and the CAPA’s arising out of the audits are closed on time.
• To prepare the performance score cards of TPM’s quarterly and ensure the compliance to the action plans .

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