Senior Specialist QA (12 months Fixed Term) (Extended Days)

​​Position Summary ​

​​The Senior QA Specialist for the Bulk Drug Substance (BDS) facility at ADMF will be responsible,with management support, for providing oversight of quality activities associated with themanufacturing and disposition of bulk drug substances at ADMF. The Senior QA Specialist is responsible for ensuring that manufacturing, testing, labeling, andstorage of Bulk Drug Substances comply with all applicable regulations. This responsibilityincludes the oversight of the College Park QMS to ensure that quality and compliancerequirements are followed in line with business needs. The Senior QA Specialist executes the site QA activities at Alexion in order to protect the safety,quality and efficacy of our products, thereby ensuring the availability of correct, safe product forour Patients, and assuring the security of the company’s business and global markets. This key role must ensure effective interaction with other departments and locations regardingGMP Document review and finished product releases. In particular, this will involve partneringwith major stakeholders such as Operations, QC, QPs, Facilities, Engineering and Supply Chain tooptimize patient supply.This position is a shift position, operating in extended days (7am-7pm, 4 days on, 4 days off).​

​​Principal Responsibilities​

• ​​Provide quality and cGMP input and oversight for all commercial manufacturing in the BDS facility.

• ​Review and approval of executed batch records in accordance with Alexion’s internal procedures and GMP principles.

• ​Reviewand approval of Master Batch Records in accordance with Alexion’s internal procedures and GMP principles.

• ​Reviewand approval of Master electronic Batch Record recipes in accordance with Alexion’s internal procedures and GMP principles.

• ​Reviewand approval of technical support documentation. (Examples include cleaning, process, method validation).

• ​Reviewand approval of functional area documentation (SOPs, Work Instructions, technical reports and protocols).

• ​Participate in quality risk assessments and provide quality oversight to ensure quality risk assessments are effectively maintained/ controlled.

• ​Provide support and expertise for inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, to monitor progress of follow up actions.

• ​Provide oversight of quality management system activities including Preventive Maintenance, Deviation Management and the Change Control Programs.

• ​Provide quality oversight of calibration and preventative maintenance criticality assessments as required.

• ​Author, review and approve Quality Related Procedures as required.

• ​Support the Supplier Management Program.

• ​Complete review and releasing raw materials and components as required to support manufacturing operations.

• ​Develop and report quality metrics.

• ​Support and act as a point of contact for the QA specialists.

• ​Deputize for the Manager, QA BDS Operations during holidays and occasion of absence, asrequired.

• ​Any other duties as required by management.

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​​Qualifications​

• ​​English fluency written and spoken (the Company language).

• ​Strong verbal and written communication skills with well-structured communication and presentation ability to various audience levels.

• ​Ability to operate efficiently in a complex matrix organization and international environment.

• ​Minimum 6 years in a quality function in the pharmaceutical and/or biotech industry with increased level of responsibility.

• ​Strong mature leadership and interpersonal influencing skills.

• ​Sound awareness and understanding of pharmaceutical business, especially with regards to quality and regulatory requirements.

• ​Demonstrated success records in auditing and improvement processes.

• ​Experience in a Lean/6-sigma operated manufacturing environment.

• ​Efficient in SAP, EDMS and MES.

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​​Education​

• ​​Academic degree in natural or applied sciences (Pharmacy, Biology, Biotechnology or Engineering).