Manager Quality Assurance

JOB DESCRIPTION:

Core Job Responsibilities:

1

Commercial Distribution Quality Assurance:

Warehouse/ CFA Audit/ Service Provider:

• Creating and maintaining warehouse/ CFA/ Service Provider audit schedule
• Conducting Internal audits of CFAs/ Hubs
• Tracking and closure of audits
• Quality visits at warehouses / CFA’s as necessary.

Managing Suppliers and performing qualification/ performance assessment/

re- qualification activities

Tracking and timely closing CAPA on identified action points arising out of:

• One Affiliate Program
• 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 Over-labelling facilities in line with Abbott standards

Reviewing temperature data of data loggers of imported cold chain products and further sharing approvals to import department

Reviewing and approving temperature excursions of products observed during storage & distribution of temperature sensitive products and description reports to mitigate product risks

Maintaining calendar for temperature mapping of Warehouse & CFA locations, reviewing and approving temperature mapping documents

Monitoring OTMS related activities at Warehouse & CFA locations and ensuring

compliance as per requirements

Trend analysis for Pest control activities and excursions

Customer Complaints handling

Receiving, logging in, acknowledging, complaint sample follow up & intimating to manufacturing site for received complaint and further supporting the investigation team

with relevant information to facilitate effective investigation.

Logging information of complaint in SolTRAQ/Trackwise.

Connecting with cross functions and Business teams, as necessary to keep the team aware

of the complaints management system and selective cases, as necessary.

Ensuring complaint sample retrieval and evaluate spread of event at Abbott C& FA as necessary.

Ensure timely response and closure of market customer complaints.

Log CAPA in system, where investigation outcome demands the same.

Ensuring the service level agreements as per the agreed timelines on customer complaints handling

To ensure Affiliate SOP is maintained aligned to EQD documents for customer complaints handling & Product actions.

To carry out trend analysis of Complaints

AQR / Consortium / Regulatory / Customer audits at Plants and Affiliate

Ensure compliance to Customer complaints related activities during audits and track for CAPA, if so arises.

To support Pharmaco-Vigilance on Global audits related to Quality sections.

Complaints from Regulators

Tracking with Regulatory & Legal team in case of FDA queries or complaints to confirm the responses are submitted on time by regulatory department.

Documentation

To perform gap analysis review wrt general compliance for local & global requirements for

the SOPs and practices followed at EPD India Affiliate on Customer Complaints handling.

Co-ordinating with Pharmacovigilance for the Health hazard Assessments submitted by the investigating teams

Filing and maintaining significant event process as per SOP

Restricting product / batch quantity in SAP

Restricting or Unrestricting stock in SAP due to Quality Reasons

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Operations Quality

DIVISION:

EPD Established Pharma

LOCATION:

India > Mumbai : BKC Building

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)