The Technical Operations Officer is responsible for reviewing executed PI sheets and batch records, completing manufacturing investigations, and closing out CAPAs following manufacturing campaigns. The role supports Manufacturing operations to assure client expectations and project timelines are fulfilled.
Key Roles / Responsibilities
* Review executed PI sheets for completion accuracy.
* Work with QA to review and close out clarifications or queries raised by the client or internally.
* Assist Senior Technical Operations Officers to complete change control actions.
* Coordinate with Document Control to ensure PI sheets are requested in a timely manner prior to manufacturing start date.
* Collaborate with Shift team leaders to request/print labels required for manufacture.
* Review and update cleaning and buffer PI sheets.
* Assist investigations resulting from process related deviations.
* Collate data required for end of campaign reports.
* Review and update SOPs, OIs and PI sheets.
* Support Senior Technical Operations Officer on project-specific tasks as required.
* Provide hands‑on support for FAT/SAT, ensuring training and documentation to optimize utilization and operational capabilities are created and available for operations.
Essential Qualifications
* Degree in a scientific subject or equivalent GMP experience.
Essential Experience
* Good chemical/bio-processing industry knowledge.
* Good working knowledge of GMP.
* Solid understanding of chemical unit operations and process chemical reaction hazards.
* Experience updating and creating batch record documentation.
* Experience implementing change using change control principles.
* Excellent verbal and written communication skills.
* Experience working in clean rooms (desirable).
Competencies
* Teamwork – Ability and desire to work cooperatively with others on a team.
* Communication – Ability to ensure that information is passed on to others who should be kept informed.
* Building Collaborative Relationships – Ability to strengthen partnerships with others inside the organization.
* Attention to Detail – Ensuring work and information are complete and accurate.
* Interpersonal Awareness – Ability to notice, interpret, and anticipate others’ concerns and feelings.
* Customer Awareness – Ability to demonstrate concern for satisfying external and internal customers.
Equal Employment Opportunity
Piramal Group is a proud Equal Employment Opportunity and affirmative action employer. We do not discriminate based on race, ethnicity, religion, gender, sexual orientation, age, disability, veteran status, and other legally protected characteristics. We base employment decisions on merit and provide reasonable accommodation for qualified individuals with disabilities.
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