Bring energy, knowledge, innovation and leadership to carry out the following:
Complete all documentation in compliance with cGMP and GxP standards.
Support review of data within the required turnaround time, including follow up and escalations as required supporting team KPIs
Prepare reports, complete review and assign comments as applicable
Operate with
proficiency in job related computer applications e.g., GLIMs, Microsoft Office
Demonstrate ability to navigate, understand and comply to company test specifications and Pharmacopeia.
Maintain clear, accurate records associated with all day to day activities.
Facilitate and drive effective communication to ensure success. Liaise effectively with external groups to ensure progress of
sample data review . 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.
Ensure training is current for all job functions performed
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.
Qualifications, Skills & Experience Required
'3 - 6 years' experience in the Pharmaceutical, Biopharmaceuticals industry.
Degree in Microbiology
Good communication, interpersonal skills and ability to work across teams.
Proven organizational skills and excellent attention to detail
Knowledge of regulatory/code requirements to
EU and US pharmacopoeia
Proficiency in English, being able to speak, read and write with minimal difficulty.
Proficiency in Microsoft Office and job-related computer applications required e.g., SAP, GLIM'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.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
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