Senior Manager- Quality Assurance at Abbott

Mumbai, Maharashtra, India

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Leverage knowledge, people networks inside and outside the company, out of the box thinking to resolve problems impacting Quality and regulatory challenges
Flexible, proactive and motivated by the opportunity to optimize structures and processes
Works collaboratively with colleagues to achieve organizational goals
Ability to adapt in a high pressured and ever-changing business environment
Ability to constructively cope with conflicts
Strong and proven analytical, organizational and decision-making skills
Strategic thinking, result and compliance oriented
Good interpersonal and communication skills
Resolution driven with adequate technical expertise
Ability to work efficiently in complex and deadline-driven operations, not losing focus on accuracy and quality
Proven track record to set priorities and adapt them accordingly at short notice
Effectively work on multiple, unrelated projects simultaneously
Provide expert guidance to team and CFTs on quality aspects and requirements supporting business
GMP and Regulatory requirement, TPM Management, Due diligence expertise
Ability to influence others. Intercultural competence
Ability to understand the impact of business development decisions and contractual language on the Operations organization
Ability to handle large volumes of confidential information and data

Responsibilities

Lead and guide the team for LLM Operations and functionality on GMP aspects and Abbott policies and procedures
Monitor compliance of Loan license manufacturing sites and TPMs
Perform LLM site visits on scheduled basis and ensure compliance of LLM sites to cGMP, Abbott policies and Procedures
Ensure Pharmacopoeial compliance of Abbott products manufactured at LLMs
Review ongoing stability data and control samples of Abbott products
Ensure implementation of Abbott quality audit CAPA & closure at LLMs
Ensure timely investigation of the Market complaints within SLA, root cause analysis, CAPA implementation and effectiveness check
Coordinate with responsible CFT for NSQ’s, Govt Agency responses
Review & assess change controls, deviations, OOS/Failures at LLM sites related to Abbott products
Ensure QTA compliance at LLMs and ensure QTAs are in place for all LL/TPMs
Monitor and support projects as assigned by the Manager
Ensure review and approve documents for tech transfer projects @ TPMs and FLQR review and approval for all projects for existing products and changes
Review of change controls and approval for products at TPMs in Abbott system
Tech Transfer at TPMs including Analytical method transfer, FLQR (First Lot Quality Review)
Ensure and review GSR notifications and timely compliance at TPMs impacting Abbott products
Ensure an effective communication process within cross functional team for execution of Quality projects supporting India Business
Ensure compliances related to regulatory changes impacting Abbott products and processes
Recruit, mentor, train and develop TPM QA India team members
Manage the CFT stakeholders including S& OP meetings, lead from the quality front
Ensure Deloitte Compliance across all LL sites including implementation of Abbott’s processes and compliance across all LL sites in coordination with LL site management
Data Management: Ensure all TPM and product related database is maintained and achieved for the TPM QA function
Customize Quality related procedures and Work instructions for the region as required for local requirement and its periodic review/ updates/ additions of SOPs to continuously improve processes and ensure compliance
Stakeholder Management: Set and manage expectations with stakeholders (Commercial, Planning, TPMs, MS&T, Regulatory, Labelling w.r.t Quality and Regulatory compliance
Support AVD projects for loan license sites and materials for requirement as per Abbott process and policies

Skills

cGMP

GMP

Quality Assurance

CAPA

Root Cause Analysis

Stability Data Review

Change Control

Deviations

OOS

Tech Transfer

FLQR

QTA

Regulatory Compliance

Audits

Pharmacopoeial Compliance

Data Management

Abbott

Healthcare solutions in diagnostics and devices

About Abbott

Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.

Lake Bluff, IllinoisHeadquarters

1888Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

Departure of key leader Dr. Adamson may affect Abbott's Heart Failure division.

Integration challenges with Medtronic could impact glucose monitor-insulin pump rollout.

Thermo Fisher's microfluidics expansion may increase competition for Abbott.

Differentiation

Abbott integrates continuous glucose monitoring with automated insulin delivery systems.

Abbott's microfluidic devices streamline diagnostic processes efficiently.

Abbott's neuromodulation products target specific nervous system areas for chronic pain relief.

Upsides

Microfluidic technology offers cost-effective solutions in diagnostics.

Strategic partnerships like Abbott-Medtronic enhance product offerings and market reach.

Significant investments indicate strong market confidence in Abbott's healthcare solutions.

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