Job Description

The Quality Assurance Release 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.

In-market quality responsibilities for products at our third-party logistics (3PL) distributors.

Education:

Degree in Pharmacy

Experience:

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 SAHPRA GMP requirements.

A good understanding of Market Authorization Holder requirements

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 biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network thatxe2x80x99s devoted to delivering a high quality, reliable supply to customers and patients on time, every time.

Current Employees apply

Current Contingent Workers apply

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: No relocation

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements: Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

MSD