Summary of Responsibilities:
These statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills, and duties.
- Review and approval of documents such as but not limited to protocols and report for Method qualification, method validation, transfer; methods; investigations.
- Handling of Quality Issues, Corrective/Preventive Actions, and Change Controls related to the client laboratories as well as their contract laboratories
- Works with the supported departments to maintain and continuously improve the quality culture to positively influence Quality KPI.
- Actively participates to meetings with business such as CAPA board, Quality improvement program and team e.g. connect meetings
Performing activities following the GMP/ safety requirements related to the assigned activity.
Key interactions areas: Drug Product development, Reg. CMC/LOC, Spec management
Knowledge of Regulatory Guidelines on dissolution studies e.g. FDA-SUPAC and ICH for validations and other emerging market like China, Latin America
Qualifications (Minimum Required):
Master’s in pharmacy or related science degree (or equivalent); or advanced degree (e.g., PhD ) as applicable. Fortrea may consider relevant and equivalent experience in lieu of educational requirements.”
Speaking-English and/or other languages as applicable
Experience (Minimum Required):
At least 8-10 year experience in analytical field is desirable
5-7 years of relevant industrial experience in Quality assurance department in Analytical science /Formulation science / material management and overall drug development and manufacturing process
Good verbal, written and presentation skills
Solid leadership capabilities including attention to detail and multi-tasking skills
Ability to interact and influence with line and middle management, global counterparts, and external contacts on a functional and tactical level
Experience in coaching project team members to strengthen their abilities and skill sets
Strong attention to deadlines and budgetary guidelines
Be able to anticipate/identify problems and takes appropriate action to correct.
Capabilities to face internal and external Audit situation.
Knowledge of medical and drug terminologies, Medical device reporting, GxPs and worldwide regulatory requirements and reporting of adverse event for both marketed and investigational products desirable
Knowledge of ICH guidelines
Preferred Qualifications Include:
Masters in Pharmacy or related science degree (or equivalent) preferred with more than 7-9 years of experience in formulation or Analytical development, dissolution development experience preferred . “Fortrea may consider relevant and equivalent experience in lieu of educational requirements.” OR
Knowledge of data management system, pharmaceutical product life cycle and Management Information System (MIS) will be preferred
Experience in DoE, Statistical expertise is preferred
Diploma or certification in Regulatory Affairs will be preferred
Work Environment:
Work environment: Office based
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