Essential Functions of the job:
· Assist in development, review, and approval of cGMP documents including, but not limited to: Master Validation Plans, FAT/SAT documents, Turnover Packages, SOP’s, specifications, traceability matrices, thermal mapping documents, and design documentation.
· Provide expertise and solutions to issues regarding CQV Lifecycle documentation in regards for applicable FDA/EMEA Regulations
· Support validation activities for project activities including review of validation documentation (FAT, SAT, URS, SDS, IQ, OQ, PQ) and attendance at validation activities.
· Provide support to enforce CQV guidelines, policies and procedures for equipment, analytical equipment, utilities, and facilities (Examples: Bioreactor, Incubator Chromatography Systems, harvest hold tank, washers, autoclaves, etc.)
· Employee will be required to work closely with Manufacturing, Validation, Site Automation, Engineer, Quality Control, and Global Technical Operations (GTS) associates.
· Ensuring appropriate investigation of validation discrepancies, errors, protocol failures, or validation testing errors requiring documented review and action to reconcile deviations.
· Undertaking any other duties for any department within the business, which may be requested by the Manager, for which training and/or an explanation has been provided and understood.
Core Competencies, Knowledge, and Skill Requirements
· Scientific degree (ideally: pharmaceutical sciences, engineering, chemistry, or related discipline).
· Minimum of 5 years’ experience in validation, biological quality assurance and/or quality control in an FDA-regulated biotechnology or pharmaceutical company with progressive levels of responsibility.
· 1-3 years in a quality assurance or quality control role in an FDA-regulated company
· Strong knowledge of cGMP’s 21CFR parts 2010 & 211, knowledge of 21CFR600 – Biologics desirable.
· Demonstrated knowledge of ISPE Baseline Guide 5, ASTM E-2500, EU regulatory requirements, and GAMP 5 Validation Lifecycle. · Knowledgeable in risk assessments and process for following well documented and thought through risk-based approaches. · Demonstrable track record and skills/experience gained within a similar position(s), at a similar level. · Good collaboration and good project management skills.
. Credible and confident communicator (written and verbal) at all levels. · Customer focused, Strong analytical and problem-solving ability. · Hands-on approach, with a ‘can do’ attitude. Able to work under minimal supervisor. · Ability to prioritize, demonstrating good time management skills. · Excellent attention to detail, with the ability to work accurately in a busy and demanding environment. · Self-motivated, with the ability to work proactively using own initiative. · Committed to learning and development. · Highly Desirable: Good IT skills e.g., Microsoft Office (Word, Excel, PowerPoint, Project and Outlook). Significant Contacts · Manufacturing, Validation, Site Automation, Engineer, Quality Control, and Global Technical Operations (GTS) associates.