QA Release Pharmacist

2 weeks ago

Midrand, Gauteng, South Africa MSD Full time

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.

Education:

  • Degree in Pharmacy

Experience:

  • Minimum of 13 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

Skills:

  • 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.
Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals worldwide.

Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that's devoted to delivering a high quality, reliable supply to customers and patients on time, every time.


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 another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Search Firm Representatives Please Read Carefully

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:
R227501

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