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QA Portfolio Development Manager ESO

QA Portfolio Development Manager ESO

Zentiva

5 - 10 years

7 - 12 Lacs

ankleshwar

Posted:6 days ago| Platform:

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Skills Required

qa selection process manager quality assurance pharmacy pharma project management agile gmp licensing operations

Work Mode

Work from Office

Job Type

Full Time

Job Description

The QA Portfolio Development Manager ESO manages all quality aspects of projects aimed to develop the portfolio of ESO products. Participates to launch management meetings and provides quality evaluation for projects lead by BD (In Licensing department and local BD) and also for projects linked to existing products. The QA Portfolio Development Manager ESO leads projects and is the quality SPoC and SME, responsible for escalation and solution preparation for non-standard project.

KEY RESPONSIBILITIES AND DUTIES

Assure cooperation with Launch Management, In licensing / local BD, and other stakeholders responsible for new business and for improvements of current business. Evaluate new projects from Quality point of view and participate to launch management and/or In licensing/ local BD meetings (if applicable).
Assure and manage the smooth transfer of new launches to a ESO QA Specialist. Support launch preparation and reescalation to launch management if and when necessary.
Conduct external audits in line with valid audit plan of CMOs.
Creation of internal SOPs.
Participate to ESO Quality management meetings
Identify gaps and propose solution to support BD, LM and other departments in case of non-standards portfolio development cases
To propose organizational and operational solutions in case of portfolio development and market extensions and transversal projects set up.
To participate on project linked to the portfolio lifecycle management and development.
Support preparation of external audit plan.
Reporting of KPI and launch status.
Assure the accuracy of ESO product portfolio database and maintained up to date.
The employee will perform other tasks under the direction of the Manager within the agreed type of work.

QUALIFICATIONS & REQUIRED SKILLS

University degree in Pharmacy, Chemistry, Biology, or relevant Life Science
Minimum of 5 years of Quality Assurance experience in a GMP related environment
Thorough knowledge of GMP requirements as well as knowledge of ICH and pharmaceutical regulatory requirements
Proven track record of project management skills
Strong communication skills and negotiation strength
Management of subcontractors is an advantage
Sense of urgency, high autonomy & agile personality
Proactive attitude
Problem solving skills
Hands-on attitude, flexible and open minded
Collaborative and team-spirited
Knowledge of IT tools
Language - English: Advanced level

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QA Portfolio Development Manager ESO