Position: Change Control Manager (Pharma Domain)
Company: Avenga
Category: Other
Experience required: 3y
English level: upper
Published: 2023-03-01T00:00:00+02:00

Avenga is looking for a Change Control Manager to join our team. Our client provides solutions that improve health and quality of life. As a part of this role, you will coordinate all aspects of software changes that are requested for validated, proprietary web applications and processes developed. You will document the description of the software change, reason for the change, assessment of the business and regulatory impact and the level of testing required, as well as a list of impacted SDLC deliverables.

**Requirements:**
-3+ years of experience in a pharmaceutical company
-Understanding of FDA Regulations, validating process against FDA;
-Knowledge of Common Pharma Domain Processes and Regulatory 
**Requirements**
-Experience with GxP Compliance;
-Understanding of CAPA.
-English — Upper-intermediate or higher.

**Responsibilities:**
-Prepare deliverables associated with computer system change control;
-Create Change Requests and validate assessments;
-Process change request documents through to closure of the documents;
-Create an annual schedule for and perform periodic reviews of validated systems;
-Prepare deliverables associated with computer system validation testing, including: risk assessments, UFRS, traceability matrices, validation plans, IQ/OQ/PQ scripts, validation summary reports;
-Review executed system testing;
-Review executed protocols.

**Your benefits:**
-Our employees get regular performance and salary reviews;
-We offer an attractive social and benefits package;
-Everyone at Avenga is subject to professional growth via our mentorship program;
-The company provides extended training and certification opportunities;
-We foster professional freedom by offering free-of-charge English courses from A1 to C2;
-We stay up to date with the industry by embarking on tech talks, webinars, conferences, and hackathons;
-Avenga cares for its employees well-being by providing well-rounded health insurance coverage and fitness compensation programs;
-Our employees’ families are no less important, as we offer maternity aid and financial support for a number of family reasons, including marriage and childbirth;
-The company fosters a sense of professional belonging and an environment of togetherness: we achieve things together and celebrate our milestones.