Job Description

WHAT YOU WILL DO:
Perform periodic review of closed out Validation Document packages and Standard Operating Procedures.
Prepare trend Reports.
Perform Qualification and validation of equipment.
Co-ordinate in the Method Transfers and Method Qualifications.
Extend documentation support to the department by participating in writing/revising of SOPs, protocols, Test reports and any other work assigned by the Senior Microbiologist/ Quality Supervisor.
Liaise with external vendors on instrument calibration and maintenance.
Solicit quotations of laboratory consumables.
Maintain continuous supply of laboratory consumables
Review of compendial and corporate policy changes.
Participate in SHE, Business Compliance, cGMP and all other compliance-related matters, where applicable.
Supervise and oversee Third Party Contractors, where applicable.
Perform method transfers/qualifications for drug substances and other drug products.
Maintain the Calibration and Preventive Maintenance Programme.
Review of compendia and corporate policy changes.
Prepare trend Reports.
Perform Qualification and validation of equipment.
Review and approve test reports log books, data sheets that are generated in microbiology lab.
Review SOPs and Protocols with relevant to Microbiology
WHAT YOU MUST HAVE:
Min Degree in Microbiology I Biotechnology.
6-8 years experience in pharmaceutical industry is preferred.
Leadership, Professional and Functional Competencies:

• Good understanding of Safety and cGMP practices
• Computer Literacy
• The experience in operating laboratory equipment and lab computer systems is very desirable.
• Good oral and written communication skills.
• Analytical development mindset in research and commercialization activities

Who we are...
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for ...
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
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Current Employees apply HERE
Current Contingent Workers apply HERE
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.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Shift:
Valid Driving License:
Hazardous Material(s):
Requisition ID: R187468