Manager QMS Quality Assurance
- Abbott
- 8 - 10 Years
- Mumbai
- 4 years ago
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Job Description
JOB DUTIES/ RESPONSIBILITIES/ ACCOUNTABILITIES:
1.Metrics & Management Review
1.1.Ensuring compliance to activities related to metrics & management review of India region
1.2.Ensuring maintenance of all necessary documentation
2. Quality Compliance
2.1.Abbott global Documents Compliance at Region
2.1.1.Ensuring timely review of draft Global documents and timely completion of Implementation Review (IRFS) for implementation of approved document at Region
2.1.2.Ensuring Affiliate SOPs/ Guidelines are developed in line with applicable Abbott global and local regulatory requirements and no past due for the region in Darius
2.1.3.Ensuring there is no excursions on any of the quality notification due to self or team, which has an impact on region
2.2. Audits at Region:
2.2.1.Corporate Quality Audit at Affiliate - Ensuring readiness for the Affiliate Audit, coordinating with stakeholders and ensuring timely development of CAPA plan & closure of all actions related audit observations
2.2.2.Corporate Quality Audit at Manufacturing Plants- Providing necessary support to sites and ensuring no critical or repeated observation on the activities handled by self or team
2.2.3.Internal audit - Ensuring readiness for the Audit, coordinating with team and ensuring timely development of CAPA plan & closure of all actions related audit observations
2.2.4.KPMG/ US finance audit- Ensure compliance to Audit observations related to SAP and Distribution Quality
2.2.5.Ensuring timely closure of all actions related to audit observations
2.3. Ensuring timely follow up and tracking of Quality Watches/ Closed Loop Audit Actions as per EPD requests
3. QA IT Systems
3.1.Ensuring compliance of the IT systems (SolTRAQs/ Darius/ ISOtrain/ SAP) as per requirements at Region
4. REGIONAL TRAINING CELL
4.1.Leading GXP training program under Regional Training Cell at all locations of Region
4.2.Ensuring Annual Training Calendar is available for Baddi, Goa, I&D, Mumbai HO, TPM QA and Warehouse/ CFA and compliance to schedule
4.3.Facilitating/ organizing/ leading training programs at Mumbai HO
4.4.Monitoring and ensuring compliance to ISOtrain at Region
4.5.Leading training excellence activities at Region
5. SAP QA Activities
5.1.Monitoring SAP QA activities and supporting team to enable successful completion of SAP Audit (by Third Party Agency/ Corporate Finance etc.) and to ensure timely completion of audit CAPA to mitigate compliance risks
6. Others
6.1.Participating actively in HIVE and continuous improvement projects as assigned by Reporting Manager
6.2.Leading Abbott Quality & Regulatory Month celebrations at Region
6.3.Performing any additional tasks assigned by Reporting Manager after completion of necessary training
Role Requirements:
- 8-10 years of relevant experience in Quality Assurance of Pharmaceutical Industry
- Experience in managing a team
- Excellent understanding on various regulatory requirements on GXP and experience in implementing the same
- Experience in developing QMS documentations such as Quality Manual, SOPs, Risk Management etc.
- Experience in handling Quality Notifications such as change control, deviations, Investigation, CAPA, internal audits and preparing audit response
- Experience in managing Quality Metrics and Management Reviews
- Experience in establishing Training Management System and conducting training on GXP topics
- Experience in handling and requirements of validation of GXP softwares such TrackWise, SAP etc. according to 21 CFR Part 11/ GAMP 5 requirements
- Shopfloor experience as a part of a manufacturing plant Quality or Production.
- Experience in managing Regulatory Inspections/ Corporate/ Customer Audits as an Auditee successfully
- Able to coordinate with cross regional/ divisional colleagues from geographically and culturally diverse teams while involving various projects
- Excellent communication skills, Training skills, managerial skills, convincing skills, negotiation skills and presentation skills
Employement Category:
Employement Type: Full timeIndustry: Banking
Functional Area: Quality Control
Role Category: Business Development Manager
Role/Responsibilies: Manager QMS Quality Assurance
Contact Details:
Company: Abbott NutritionLocation(s): Mumbai
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