QA Specialist

219
Job Description

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 committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

The QUALITY ASSURANCE SYSTEMS SPECIALIST is responsible for assisting in enhancing Quality Systems by taking responsibility and being accountable for all the primary activities listed below. The QUALITY ASSURANCE SYSTEMS SPECIALIST must comply with MERCK Standards and other regulatory requirements.


Primary Activities

Compiling data for the compilation of Annual Product Review (APR’S) as per an approved schedule from batch documents, completed APR’s and various other GMP documents.

Compile and manage a data base for collation of APR’s.

Compiling an APR.

Technical review of a completed APR.

Compile and update QS SOP’s.

Archiving and linking Midrand site data to the MSD archiving system (HPRM).

Ensuring the effective identification of CAPA and close out of CAPA actions within due dates.

Maintaining the retention store (fridge and ambient).

Managing filing of Quality Documentation (capturing, filing and archiving).

Participate in company training programs to support the company vision as well as any other training to ensure effective fulfilment of duties.


Qualifications/ skills

Minimum tertiary degree (BSc) or related discipline.

Knowledge of Good Manufacturing Practices and regulatory requirements

Problem solving skills. Able to deal with situations requiring interpretative and evaluative thinking. Able to make unbiased and honest judgements.

Proficiency in Microsoft Word and Excel software.

High Technical Skill.

Attention to detail.

Problem solving skills (ability to identify risks/gaps, assess the impact and recommend actions for correction)

Good oral and written communication skills


Experience required

At least 2-3 years’ experience in the pharmaceutical industry

Understanding of GMP particularly with reference to packing operations.

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 …

Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.

We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.


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.


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:

Temporary (Fixed Term)
Relocation:

No relocation
VISA Sponsorship:


Travel Requirements:


Flexible Work Arrangements:


Shift:


Valid Driving License:


Hazardous Material(s):


Number of Openings:

1


Requisition ID:
R30502

Apply here!

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