Senior Manager- Quality Assurance

Abbott

12 - 15 years

35 - 40 Lacs

mumbai

Posted:1 day ago| Platform:

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Skills Required

tpm manager quality assurance sap team management data management pharma analytical quality audit manager quality control gmp

Work Mode

Work from Office

Job Type

Full Time

Job Description

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 of 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.

Expectations & Skills :

Leverage knowledge, people networks inside and outside the company, out of the box thinking to resolve problems impacting Quality and regulatory challenges etc. impacting Abbott business.
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 an 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.
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 and be able to determine how and when to inform upper management on quality related matters. Have a good control on Product database related to Quality.

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