Job Description As a QA Pharmacist, you will be responsible for ensuring all products are released for sale according to Good Manufacturing Practice (GMP) requirements. The position is critical in ensuring quality standards, processed and specifications are in line with registered information and global GMP requirements. Collaboration and a high degree of accuracy is required to ensure compliance with the Company's quality systems.The role also requires the ability to play a role in system ownership for the release, deviation management and quality risk management and change control systems during Health Authority inspections as well as divisional audits on site.
Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.Key responsibilities:Ensure all products are released for sale to South Africa and other countries in Africa according to GMP requirements. Review of batch documentation and relevant records and reports prior to release. Manage rejections and returned stock where necessary.Ensure Quality standards/specifications and methods are in line with Regulatory dossier and are maintained current.Participate in the change control system including supplier change management.Participation in deviation management, execute deliverables where required and approval of investigation reports.QA review and approval of artworkParticipates in Quality Risk Management.Provide technical knowledge and remediate selected quality system gaps as a result of new or revised Quality Standards and ensure that practices in the relevant systems are in alignment with internal SOP’s and guidelines.Participates in Communities of practice and rolls out learnings to the site.Ensure regulatory documentation and database is adequately checked against the in-use specifications and requirements for release.Liase with external and overseas laboratories and local contractors as required in relation to quality matters.Participate in activities related to new product introductions.Participates in Manuacturing Lean activities.Participates in activities of the Site Quality Council.
Minimum tertiary degree in Pharmacy and registered as a Pharmacist in SA.
A minimum of 3 years experience in the pharmaceutical or related industry .
Knowledge of pharmaceutical 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.
Good oral and written communication essential.
Flexibility and willingness to seek opportunities for continuous improvement.
(An understanding and experience in an analytical laboratory with a knowledge of HPLC and other main instrumental techniques is an advantage).
Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time.
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.
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 for the common good. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
Search Firm Representatives Please Read CarefullyMerck & 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.
No Travel Required
Flexible Work Arrangements:
1st - Day
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