12 MONTHS

Job Description

• You will predominantly support all activities associated with Commissioning & Qualification of Equipment and Process associated with B200 Flu Manufacturing Facility.
• You will also be required to review and approve Analytical Instrument Qualification documents associated with various analytical instruments like HPLC, UV/VIS Spectrophotometer, etc.
• You will be responsible for reviewing and approving specifications, qualification protocols, data packs and qualification summary reports associated with Facility, Utility and Equipment’s (FUE) and Process (MTech Studies) associated with B200.
• You will also apply and interpret cGMP, regulatory requirements, standard, directives and guidelines from Corporate Quality management and regulatory agencies, to ensure records are clearly and appropriately justified.
• You will represent Quality Operations in various meetings for the FUE and Mtech Studies and will provide guidance adhering to Global Quality Directives, Pharmaceutical Industry Standards (i.e., GAMP, ICH, ANNEX), Code of Federal Regulations.
• You will be responsible to support Environmental Monitoring (EM) associated documentation (Strategies, SOPs, Protocols, Raw data review, Reports, etc.)
• You may be required to work flexible hours in order to meet project timelines.
• Candidate will be required to be fully fascinated (Flu shot) in order to enter new Building

Necessary Skills:

• Strong Quality Mindset
• The ability to effectively communicate, both verbally and in written format, through multiple layers of the organization and the ability to think strategically are key to the individual’s success.
• Excellent interpersonal and influencing skills and must be able to work in a cross-functional team-based environment
• Strong technical background and knowledge in both FDA/EU quality compliance requirements and validation requirements.
• Ability to work in a diverse environment and draw upon experience in determining the actions needed to achieve results and remediate issues.
• Ability to work in a fast paced environment and make balanced quality decisions.
• It would be preferred if the candidate has experience with Document Management Systems (such as QualiPso etc.) applications and trained in Change Management, Nugenesis, Kneat Paperless Validation system etc.
• Demonstrated ability to meet/exceed timelines/deliverables.
• Experience with computerized systems validation, validation of Delta V, Data Historian OSI PI, and Manufacturing Execution System MES is an asset.
• The individual with experience of supervising third-party manufacturers (for SUS etc) for GMP compliance as with regards to documentation would be an asset.

EDUCATION

Bachelor’s Degree in the field of Science or Engineering, with 5+ years of experience in a GMP-regulated environment. Minimum 5 years experience in review and auditing of GMP documentation. The candidate will support all activities associated with the Commissioning & Qualification of Equipment and Processes associated with the B200 Flu Manufacturing Facility. Candidate will be responsible for supporting Environmental Monitoring (EM) associated documentation (Strategies, SOPs, Protocols, Raw data review, Reports, etc.)

TB_E

Please refer the Job description for details