Pharmacovigilance: Responsible for reporting adverse experiences or events (AEs), adverse device events (ADEs), product quality complaints (PQCs) and other reportable information, customer feedback (CF), alleged counterfeiting, diversion and tampering (CDT) that they become aware of to the Designated Point of Contact (DPOC)
Job Description
- Organise Calibration and preventative Maintenance schedules internal and external.
- Request Quotations from suppliers and Generate Purchase Orders for any Laboratory consumables and QA Monthly checking of expired reagents and consumables required for ordering
- Management of reference standard by checking expired reference standard, ordering and updating the spreadsheet.
- Manage HPLC columns according to vendor recommendations and good GLP and manage HPLC Column Spreadsheet
- Write and update Lab SOP’s
- Manage CAFU actions for the Lab to ensure no overdues and writing of closeout memo
- Initiate Change Control
- Perform monthly PM’s
- Perform Gap Assessments
- Perform Monthly Environmental Monitoring
- Organise any corrective maintenances/ repairs required in the lab
- Prepare document required by Auditors prior to Audit Filing of documents
- Perform weekly sampling of water, send samples for micro testing and document results upon receival
- Adheres to data Integrity Principle
- Monitor EMS data on lab fridges and freezers on weekly basis
- Maintains clean and tidy workbenches and Laboratory to ensure that the Laboratory housekeeping is in compliance with housekeeping and Chemical Hygiene Plan guidelines.
- Promptly reports any problems requiring unplanned maintenance to the QC Laboratory Lead and initiates necessary documentation when required
- Ensures safety rules and adhere to at all times
- Participates in company training programs to support the company vision as well as any other training to ensure effective fulfilment of duties.
Qualifications/ skills
- A Tertiary degree in Chemistry or a diploma in Analytical Chemistry.
- Minimum 2 years’ experience in a Pharmaceutical
- A sound knowledge of analytical techniques
Experience required
- Computer literate, in particular Windows environment, WORD and EXCEL
- Ability to work accurately and fast
- Change agile and pro-active
- Technical and mathematical skills
- Good verbal and written communication skills
- Responsible, accountable and reliable
Our Human Health Division maintains a “patient first, profits later” ideology. The organization is comprised of sales, marketing, market access, digital analytics and commercial professionals who are passionate about their role in bringing our medicines to our customers worldwide.
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. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
INVENT.
IMPACT.
INSPIRE.
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.
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:R112472