Manager Quality Assurance Job in Abbott Laboratories

JOB DUTIES/ RESPONSIBILITIES/ ACCOUNTABILITIES:

DISTRIBUTION QUALITY (COMMERCIAL & DISTRIBUTION QA)
Warehouse/ CFA Audit:
Creating and maintaining warehouse / CFA audit schedule
Conducting audits as per schedule
Tracking and closure of audits
Creating & maintaining warehouse / CFA training schedule and executing the same
Tracking and timely closing CAPA on identified action points arising out of:
Abbott Affiliate Audit
Regional Supplier Audit
Regulated monitoring activities
Exceptions
Identification, preparation, review and updating of Distribution Quality SOPs/ Quality Manual/ documents meeting requirements of regulatory and Abbott (Corporate & Divisional documents)
Ensuring over labeling controls at approved Overlabelling facilities in line with Abbott standards
Verification of artwork proofs of Avene / PFDC products (direct import and market) against approved artwork and release the same
Uploading and reviewing data loggers of cold chain products into Global software and further sharing approvals to import department
Leading distribution quality excellence activities at EPD India region
Influvac Management
Tracking and confirming reference standards availability by coordination with import department
Ensuring on time toxicity testing from approved public testing lab for every consignment
Maintenance of Product List of EPD - India
Updating product list on a monthly basis, by coordinating with plants & TPM QA on technology transfers, FLQRs or any other changes of the month
Summarize and share the list of changes in Global format for updating in SolTRAQs
Maintaining and sharing product list on a quarterly basis to internal stake holders as well in compliance to Quality Manual
Sharing updated product list / addendum to storage condition list to Distribution team
HO Functions
Ensure compliance to Audit observations related to SAP and Distribution Quality of:
KPMG
US finance audit
Consortium Audits / AQR audits
SAP activities
Overseeing SAP activities and ensuring correctness and compliance of the activity
Consortium Audit at Warehouses / CFAs
Ensuring no major or critical observations in Consortium audits related to Distribution quality
Ensuring acceptable CAPA availability and timely closure of CAPAs of audit observations
Others
Performing any additional tasks assigned by Reporting Manager after completion of necessary training

Role Requirements:

• 12-16 years of relevant experience in Distribution Quality Assurance of Pharmaceutical Products meeting Good Distribution Practices
• Experience in Quality Auditing of Warehouse/ CFA. Auditor certification (i.e. by ASQ/ ISO) is plus
• Experience in Training people on GXP topics
• Experience in handling GXP softwares such TrackWise, SAP etc.
• Experience in managing a team
• Able to coordinate with cross regional/ divisional colleagues from geographically and culturally diverse teams while involving various projects

Excellent communication skills, managerial skills, convincing skills, negotiation skills and presentation skills