A leading biopharmaceutical manufacturer is seeking a QC Technical Expert. Initial 12 month contract. The candidate must have a strong technical knowledge of analytical techniques and strong knowledge of related laboratory equipment in one or more of the following areas: Chemistry, Biochemistry, Bioassay or Microbiology. The individual will be responsible for: Qualification of analytical equipment and related testing functions, for example HPLC, Spectrophotometry, Nephelometry, Endotoxin, Cell Culture and Total Organic Carbon etc. Sampling and testing coordination during plant and laboratory utility qualification. Co-ordinates & plans activities related to the successful transfer of Analytical Methods for relevant NMEs. Co-ordination of Raw material, Utilities, In Process, Final Bulk and Final product analytical testing and sampling. Support and Implementation of Analyst Training programs. Partners with other Departments and Team Leaders to ensure that activities related to QC are completed in an efficient manner. GENERAL SCOPE OF RESPONSIBILITIES: Supports Team leader on day to day testing operations. Performs Data and QC Investigations review and approval. Reviews and approves deviations, CAPAs and Change Control. Plans and oversees lab related projects, i.e. Method transfers, Equipment, Qualification etc., Proactively identifies and drives lab process improvements. Trains laboratory team on specific analytical technology. Provides subject matter expert technical support on specific analytical technology. Supports lean initiatives in the area of lab operations i.e. test method execution, documentation updates and equipment qualification etc., Presents technical analytical clearly and concisely data to customers, internal investigations and regulatory inspectors, etc., Keeps abreast of analytical technology and compliance trends. QUALIFICATIONS AND EXPERIENCE: Bachelors Degree in Chemistry ,Biochemistry, Micro or science related field. 4-6 years related experience in biopharmaceutical or pharmaceutical industry. And/or an equivalent combination of education and experience. Working knowledge of regulatory requirements, policies and guidelines. Experience with Quality Control document reviews and regulatory inspection processes. Working knowledge of Quality systems. Strong technical knowledge in and experience with QC analytical testing methods and equipment is required. Knowledge of cGMP regulations and FDA/EU guidance is required. ESSENTIAL: Support cGMP routine testing required for deviations, laboratory investigations, CAPAs and out-of-specification (OOS) results. Perform data review assignments in accordance with the established laboratory procedures on data integrity and documentation. Drive, author, and review laboratory documents, such as protocols, reports, standard operating procedure, work instructions and other quality documents as per requirement. Operate and provide support for overall laboratory instruments/equipment as per requirement. Lead and provide training to colleagues as SME. Initiate change requests with applicable procedures /policies. Escalate any non-conformances noted immediately to the supervisor/ in-charge, initiate Quality Issues identified as per applicable procedure, participate in the investigation, perform investigation analysis, and provide necessary information to enable implementation of effective CAPA. Provide strong technical/scientific support to internal and external customers when needed. Support qualification or validation methods to be used by the Quality Control unit. Participate and lead in special projects as QC analytical technical team member. Ensure effective capacity planning and performance management of the task assigned.
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