Job Title: Quality Assurance Assistant
Company Operations: We are a veterinary pesticides manufacturing facility looking to recruit qualified personnel to oversee activities at our manufacturing unit.
Overall objective of the position: The Quality Assurance Assistant’s key role is to ensure quality compliance with Good Manufacturing Practices (GMP) and the company’s Standard Operating Procedures (SOPs).
This function also ensures the timely release of incoming product batches into the marketplace for sale.
Responsibilities:
· Manage the Quality Control/Quality Assurance function including but not limited to: lot management, stability review, temperature monitoring, maintenance of quality agreements, release of products for sale, product inspection (audits) and preparation and development of Standard Operating Procedures.
· Document management, archiving of QA/QC records and responding to any Compliance related issues.
· Assist Regulatory projects that involve QA oversight including stability changes, updates to labelling etc.
· Manage and evaluate (trending) product complaints, deviations, Corrective Actions and Preventative Actions (CAPAs)
· Development, review, revision and implementation of SOPs as required.
· Annual product reviews and review of stability reports for compliance with Registration requirements.
· Act as primary quality contact person with Third Party Logistics (3PL) and as qualified person for internal quality compliance matters
· Implement recall procedures if necessary and perform mock recall yearly to ensure recall procedures are adequate.
· Monitor QA aspects of warehousing and shipping practices for compliance with warehouse procedure manuals.
· Liaise with customers and regulatory authorities regarding quality matters, including hosting inspections and responding to observations.Quality Control.
· Timely approval of incoming batches, batch inspection and perform release procedures according to SOPs
· Maintain appropriate documentation (i.e., CoA’s) and ensure document compliance according to GMP.
· Manage deviation reports.
· Manage customer returns.
· Managing off site retained samples according to GMP
· Maintain QC master documents for all products.
· Ensure compliance with appropriate SOP’s, policies and guidelines.
· Complete mandatory training in assigned timelines upon hire as well as when new policies, SOP’s, guidelines are issued.
· Execute other duties as may be required by Management from time to time.
Key working relationships:
· Interface and cooperation with internal functions or external partners
Experience:
· 2-4 years in a similar position with busy working Experience-Pharmaceutical Industry
· Diploma in Biochemistry
How to Apply
If you are up to the challenge, possess the necessary qualifications and experience, kindly send your detailed CV quoting the job title on the email subject “Quality Assurance Officer” to: vacancies@jantakenya.com by or before 3rd January 2023.
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