Job Title: Pharmaceutical Production Specialist
Role Summary: We are seeking a skilled and experienced Pharmaceutical Production Specialist to join our team. The successful candidate will be responsible for maintaining detailed production processes, ensuring the highest quality standards are met, and supporting scientific innovation.
Responsibilities:
* Set up and operate pharmaceutical production equipment, including high-speed filling lines for sterile products, autoclaves, washers, depyrogenation tunnels, formulation processes, HMI, CIP/SIP processes, and inspection and packaging line equipment, following SOPs and Batch Records.
* Complete formulation activities, including dispensing drug substances and excipients.
* Prepare, wash, sterilize materials and parts.
* Handle packaging and transfer of final products to the freezer.
* Complete necessary training prior to task execution.
* Perform all transactions at each manufacturing step using SAP.
* Adhere to aseptic techniques and practices for aseptic operations.
* Maintain and clean production equipment and classified areas.
* Conduct routine QC sampling and in-process testing.
* Complete batch records and logbooks in compliance with GDP.
* Transfer materials for batch manufacturing.
* Prepare filters for testing and perform FIT (Filter Integrity Testing).
* Load and unload equipment during production activities.
* Monitor stock levels and inform management of material requirements.
* Ensure safety and quality compliance, reporting anomalies promptly.
* Participate in EHS, Business Compliance, cGMP, and other activities.
* Report quality issues immediately.
* Perform microbial sampling and swabbing if required.
* Liaise with vendors for calibration and maintenance.
* Conduct calculations for product potency and endotoxin levels if necessary.
* Inspect, label, and package finished products, and perform in-process sampling and inspections.
* Undertake additional duties as assigned.
Qualifications:
1. Minimum