Specialist- Quality

Merck Sharp & Dohme (MSD)

6 - 7 years

8 - 9 Lacs

pune

Posted:6 days ago| Platform:

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Skills Required

pharmaceutical six sigma sap quality control quality audit iso computer application regulatory spc problem solving quality analysis quality systems qc quality management fmea safety quality assurance qms ppap communication skills inspection

Work Mode

Work from Office

Job Type

Full Time

Job Description

Operate as part of the QC team according to Company safety policies and cGMP to drive compliance with our companys Global policies, procedures, guidelines and regulatory requirements in the performance of all applicable job functions.
Complete all documentation in compliance with cGMP and GxP standards.
Perform receipt and release of all materials ensuring QC Right First Time and turnaround time KPIs are achieved.
Review of all vendor and external laboratory documentation associated with receipt and release of materials to ensure compliance with internal specifications and Pharmacopeia.
Maintain clear, accurate records associated with all day to day activities.
Demonstrate proficiency in job related computer applications e.g., SAP, LIM s
Demonstrate ability to navigate, understand and comply to company test specifications and Pharmacopeia.
Facilitate and drive effective communication to ensure success. Liaise effectively with external groups to ensure progress of material receipt and release. Collaborating with others by sharing your skill set and expertise.
Support and participation in Internal Investigations Ensure that all Quality Systems within the department are adhered to on a daily basis.
Problem solving to get to root cause of issues.
Provide support with audit/inspection requirements to ensure department compliance/readiness.
Participate in internal and external audits and inspections.

Qualification and Experience:

Minimum 6 years experience in the Pharmaceutical, Biopharmaceuticals industry or a similar operating environment which includes experience in a Quality function.
Degree in Science, Engineering or similar
Good communication, interpersonal skills and ability to work across teams.
Proven organizational skills and excellent attention to detail
Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
Proficiency in Microsoft Office and job-related computer applications required e.g., SAP, LIM s
Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance.
Demonstrated ability to drive the completion of tasks.
Proven decision-making capability with accountability and responsibility.
Demonstrated ability to solve problems.

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