Senior Specialist

Bristol Myers Squibb

3 - 8 years

5 - 10 Lacs

hyderabad

Posted:15 hours ago| Platform:

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Skills Required

product quality automation process improvement pharma project management clinical trials data privacy gmp risk management recruitment

Work Mode

Work from Office

Job Type

Full Time

Job Description

Responsible to provide oversight and completion of the site APQRs
Responsible for authoring of APQRS assigned, per site APQRs per schedule
Responsible for ensuring any site or CMO APQR is created following the effective process and procedures
Provide in depth quality and compliance oversight during report authoring.
Responsible for ensuring all elements of the AQPR procedure are fulfilled accurately.
Responsible for facilitating review and approval meetings, problem-solving key issues, and effectively managing communications with key stakeholders.
Responsible for collecting review feedback and resolving comments and questions.
Responsible for projecting and communicating stakeholder actions and timing.
Responsible to escalate any deficiencies in the draft APQR which cannot be resolved with the working team
Responsible for escalation of risk to not meeting the completion date.
Responsible for providing opportunities for process improvement.
Accountable to adhere to GMPs and BMS Policies and Procedures
Support as may be required, the implementation and/or maintenance of additional QA Systems, which may include (but is not limited to) APQR program documentation, Change Control, Quality Risk Management, Product Quality Complaints and Annual Product Quality Reviews
Support as required Digitalization / automation / efforts for the APQR program

Qualifications & Experience

Specific Knowledge, Skills, Abilities:

Understanding of Biologics, Pharmaceutical, and/or Cell Therapy operations and processes required.
Works with the routine oversight on direct manager.
Experience in a GMP Quality role required
Experience in authoring APQRs
Prior experience with navigating Quality Management systems.
Demonstrated tactical thinking capability with strong project management skills.
Ability to work in a global environment.
Demonstrated negotiating and influencing skills in a matrixed organization.
Ability to build strong relationships by being transparent, reliable, and delivering on commitments.
Effective communication skills.
Ability to provide innovative ideas, align and make decisions balancing speed, quality, and risk.
Fluent in English, with proven professional working proficiency in English for reading, writing and speaking.

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