Title: Officer

Position- Officer API Production

Qualification – B.Sc./ M.Sc.

Exp- 3 to 8 Years of experience

Job Description- Officer Production Penam

Candidate from API regulatory plant will be preferred

Job Responsibilities :-

• Carrying out the batch operations with safety, cGMP and SOP.
• BPR filling & on-line documentation and maintain the adequacy & accuracy with respect to data integrity.
• Maintain SOP compliance records with accuracy.
• Charging of batches & batch processing as per BPR & SOP.
• Handling and operation of the equipments as per SOP.
• Cleaning and sterilization of equipments and integrity testing of sterile grade filters.
• Planning the work of technician and follow up.
• To maintain housekeeping of owned area such that efficacy, purity and safety of product is ensured & ensure the cleanliness of equipment and its surroundings.
• Effective communication to superiors as well as subordinates in order to carry out work and its follow up according to instructions.
• Ensure good housekeeping in surrounding working area and personal hygiene.
• Sterilized articles unloading from sterilizer and transferring to respective place and aseptic connection.
• Execution of process simulation, validation / revalidation, qualification, requalification of equipments and system as per protocol.
• Coordination with IPQA, QC and Micro for PCO, Campaign changeover cleaning and In process sampling.
• Environmental monitoring of controlled and critical area.
• Review of Calibration reports, FMS trends and alarms.
• Calibration of sensors (Steam sterilizer, DHS and Kaye Validator).
• Checking of Raw material and Packing material, labeling and packing of FP.
• Verification of all critical routine operations.
• To perform & verify the cleaning & sanitization of articles, equipments & area as per respective SOP.
• To Complete all assigned training on time.
• To Maintain shop floor discipline and ensure harmonious relationship among employees
• Execution of Protocol based activities
• To be on their dedicated workstation & proper hand over the charge to another employee (who is well trained to perform the task) and inform his superior prior leaving the workplace.
• To do the entries of records as per their respective SOP’s (equipment log book, cleaning records etc.)
• To Check the entries recorded by doer as per respective SOP’s (equipment log book, cleaning records etc.)