About this role
We are currently looking to identify outstanding and qualified resources with experience in any of the following areas to join our team.
CLEANING (Calculate contact surface area, establish acceptance limits and sampling plan, development of reports and master plans)
EQUIPMENT (Understand concept of Design Qualification, experience in FAT, IQ, OQ, PQ for Lab, manufacturing & packaging equipment)
PROCESS (Understand the relationship between process parameters, quality attributes, acceptance criteria and the lifecycle approach)
STERILIZATION (Prepare and calibrate TC’s, autoclaves, SIP’s, P & ID’s, knowledge in using Kaye Validator)
QUALITY (Strong experience in Investigations and CAPA (using Trackwise or SAP), generation and administration of Change Controls. Strong knowledge and experience in Regulatory area)
Able to integrate into a dynamic cross-functional team responsible for supporting/implementing activities.Develop and execute protocols and prepare final reports following plant procedures and regulatory requirements. Analyze data, and present conclusions and recommendations to clients. Organize, schedule and track projects in order to meet client requirements within agreed time lines.
A minimum Bachelor's degree in a related science (Engineering, Chemistry, Biotechnology or Life Science) Experience working in a FDA Regulated environment. A thorough knowledge of Good Documentation Practices (cGDP), excellent verbal and written communication skills. Experience in writing technical documents, including validation documents (protocols and reports), assessments and investigations. Excellent interpersonal skills, coupled with a superb attention to detail, excellent review and analytical skills. Must have strong ability to organize and manage multiple tasks in a fast-paced environment. The ability to work effectively with team members and work under minimal supervision.Filed experience in validation equipments.
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