Stegram Pharmaceuticals strives to be the premier provider to the pharmaceutical and medical industries for the development and commercialization of new medical therapies worldwide.
Our mission is to combine the strength of our expertise, experience and innovation to advance the worldwide success of the pharmaceutical and medical industries in preventing and curing disease. We believe in our values; Integrity and Ethics, Client Service and Quality, Innovation, Sense of Urgency, Open Communication, Initiative and Reward, Teamwork and Ownership.
Position Profile
Stegram Pharmaceuticals is seeking a QA Officer on a permanent basis. In this role, you are responsible for planning and execution of daily quality assurance activities while ensuring compliance with international quality requirements as defined by the applicable guidelines (e.g. FDA, EMA, ICH) and all existing GMP standards in responsibility. This position involves judgement of batch related documents.
Key Functions *Plan and execute quality assurance activities (document management, batch records and label issuance, batch record review, equipment and supplier qualifications etc.) including documentation. *Monitor compliance with all applicable GMP and safety standards. *Support the Qualified Person in his role, including audits and quality training. *Write, review and approve documentation (SOP’s, manufacturing and quality instructions, *validation of protocols and reports, non-conformities, change requests). Handle, distribute and archive controlled documents. *Prepare data for trending (QRB, Annual Product Review) and support internal and external audits.
Knowledge, Skills, and Abilities *BSc in chemistry/biotechnology. *Knowledge of GMP is an advantage. *Good communication skills in English. *Accuracy, tidiness, self-organized, flexible, attention to detail, team player. *Proactive thinking team-player, accurate, precise and constructively critical.
Stegram Pharmaceuticals is an Equal Opportunity Employer.If you would like to join the Stegram Pharmaceuticals successful growing team, we would love to hear from you! Send in your CV to our via email: careers@stegrampharm.com