QA Officer (External)

Come and Save Lives with Us!

SERB Pharmaceuticals is a growing international specialty pharmaceutical group that is a dedicated ally to healthcare providers treating patients with critical conditions, focusing on emergency care and rare diseases.  We have over 470 employees in 16 countries and a group revenue in excess of €350m.

Our portfolio 80+ rescue medicines make a real difference in the lives of patients and their caregivers and that gives every one of our employees a sense of purpose.

Our Purpose is supported by our 4 key values:

• We make patients our priority
• We act with integrity and accountability        
• We work together as one team         
• We look for better ways forward       

Broad Function
New Quality Team Officer being a part of an innovative Biotech oriented organisation that is a fast-paced company which strives to supervise and support external service at the highest level, and provide its employees with a platform to learn and grow.
This role involves working closely with contract manufacturing organisations (CMO) and contract testing labolatories (CLT). It also requires dealing with a multiproducts and multicontractors sites that provide full spectrum biopharmaceutical manufacturing services in the production of bulk Active Pharmaceutical Ingredient (DS) and Drug Product (DP).

Principle Responsibilities

• Create and enhance collaborative and trusting relationships with external manufacturing sites and internal SMEs and establish effective communication.
• Responsible for Quality Assurance oversight of the external manufacturing operations and related projects to ensure the corresponding GMP compliance in every phase according to regulatory expectations. This includes:
• Provide guidance and supporting external manufacturing with Product Disposition;
• cGMP Document Review; involving reviewing both master and executed Batch Manufacturing Records, validation/qualification protocols and reports;
• Coordination/support for batch release, supporting QPs in the batch certification process;
• Arranging, attending, taking minutes from calls with CMOs/CTLs and tracking actions;
• Supervise and assess the changes that affect external manufacturing including but not limited to: facility, equipment, raw materials, test methods;
• Support, review and approve External Investigations and ensure issues are tracked within company QMS system;
• Ensure escalation of substantial issues to the Quality Assurance Manager;
• Ensure External manufacturing risks are adequality addressed within site Risk Management Processes.

Education and Experience

• Life science degree including Biology, Micorbiology, Biochemistry, Pharmacy, Chemistry or Biotechnology (or equivalent) is preferred.
• Experience dealing directly with both regulatory agency personnel as well as the CDMO provider representatives is preferred.
• GMP Knowledge (EU and FDA) with practical application. 
• Experience in operational GMP in a pharmaceutical manufacturing environment including batch disposition.
• Experience in working in a multidisciplinary environment and supplier relation management is preferred.
• Preferable have at least 3 years experience in Quality or Quality Assurance functions within the Pharmaceutical or Medical Device Industry is required.

Skills and Attributes

• Understanding of the regulatory/Quality responsibilities active pharmaceutical ingredient (DS) and drug product (DP) batch disposition.
• Familiarity in several elements of pharmaceutical manufacturing.
• Good written and oral English communication skills.
• Ability to respond to common inquiries, regulatory agencies, or members of the business community.
• High tolerance for ambiguity in a complex environment. Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
• Ability to build partnerships both internally and externally. 
• Ability to think and act independently.
• Demonstrated negotiation and influencing skills.
• Knowledge of MS Word, Excel, PowerPoint and data management platforms.
• Willing to travel within UK, EU and internationally for up to 15% of time
• Strong written, verbal and presentation skills.
   

Serb Pharmaceuticals is an equal opportunity employer. We offer competitive compensation & benefit packages, challenging opportunities and a culture of working together in a supportive way built on our strong foundation of values.