Deliver consulting projects in the process-related areas including but not limited to Technology Transfer, Cleaning Validation (CV), Sterilization-in-Place (SIP) PQ, Process Qualification, Shipping Validation and Process Validation.
Draft CQV deliverables such as URS, risk assessment, data integrity related assessment and CV / SIP PQ / PQ / Shipping Validation / PV protocols.
Execute CQV protocols and draft reports.
Draft validation strategy for CV, SIP PQ, process qualification and process validation.
Draft protocols for process comparability, resin lifecycle management, stability study and other process related protocols.
Draft Technology Transfer documentations such as facility fit assessment, control strategy, etc.
Support business and service development initiated by the management of Orka.
Requirements:
Hold Bachelor's degree in Life Sciences, Engineering or related field.
Have worked for at least 3 years in pharmaceutical, medical device or related environment.
Fresh graduates with internship in pharmaceutical or medical device industry and some relevant experience may apply for a Junior role.
Have working experience in MSAT or pharmaceutical process related roles.
Have working knowledge of DeltaV including for logics such as handshakes and prompts
Have working competency in the area of Fermentation, Centrifugation, chromatography and/or TFF/UFDF processes.
Have good understanding of regulatory requirements and relevant industry best practice.
Why Join Orka:
Work that Matters: Support clients bringing innovative and life saving solutions to the population.
Career Development: Build a consulting career in a professional consulting company with Life Sciences focus.
Professional Environment: Work with similar professionals possessing Intelligent, Resourceful, Loyal and Teamwork characteristics.
Impactful Learning and Mentoring: Develop yourself in an environment that heavily foster learning attitude and benefit from access to training materials, references, mentors and management with wide range of regulated industry experiences.
