The Quality Assurance Pharmacist will have responsibility to ensure all products are released for sale according to Good Manufacturing Practice (GMP) requirements and within set timelines.
The position ensures quality standards, processes and specifications are in line with registered information and global GMP requirements.
Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.
Primary Responsibilities
- Management and oversight of the release of all finished, packaged product to the market.
- Management and oversight of the release of bulk product for primary and secondary product packaging.
- Management and oversight of the release of fully packaged & imported products.
- Implementation of and adherence to our Company's global and Health Authority requirements for batch disposition.
- Participation in deviation classifications and investigations, Quality Risk Management and Change Control Systems.
- Participation in Health Authority and Global quality audits.
- Participate in and lead [as required] meetings, problem solving sessions and strategy development plans with company representatives for which our Company operates as a Contract Manufacturing Organization.
- Management of retention samples.
- Ensuring that bulk and product are released on time as per the Company's scheduled release dates.
- Collaborating with the Quality Control lab, warehouse, production teams to ensure release of bulk and product on time as per the Company's set release dates.
- Degree in Pharmacy
- Minimum of 1-3 years managing product releases end to end in the pharmaceutical industry.
- Experience in the Quality Assurance pillar
- Experience in Good Manufacturing Practices
- A good understanding of Health Authority requirements
- A good understanding of Market Authorization Holder requirements
- Experience in a senior role is an advantage but not a requirement.
- Experience in SAP
- Effective Collaboration skills
- A high degree of accuracy is required to ensure compliance with the Company's quality systems.
- Effective communication skills [written and verbal]
- Proactive
- Agility
- Results driven.
Who We Are
We are known as Merck & Co., Inc., Rahway, 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.
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 anothers 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., 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
VISA Sponsorship
Travel Requirements
Flexible Work Arrangements
Shift
Valid Driving License
Hazardous Material(s)
Requisition ID R227501
