Compounder
Sun Pharmaceuticals, Inc
Job purpose
Responsible for the cleaning, setting up and operation of manufacturing equipment as part of the process of compounding pharmaceutical creams, ointments, gels and liquids.
Duties and responsibilities
Complete G.M.P. documents, such as the Batch Record, cleaning & sanitizing logs, housekeeping logs and other documents / log records pertaining to manufacturing
Follow safety rules/regulations and report any workplace injuries or accidents. Assist when required to improve equipment safety related procedures. Wash and sanitize compounding rooms and vessels
Compounding batches as per SOPs and Master Formulas. Report discrepancies and deviations in a timely manner to compounding lead hand or supervisor
Dispense raw materials when required
Perform accurate inventory transactions using SAP
Maintain a clean and organized working environment. Familiar with 5S processes and Lean Manufacturing Concepts
Participate and assist with continuous improvement projects and processes
Work safely and accurately with a focus on completing tasks and documentation right first time
Complete all GMP Documentation correctly and in a timely manner
Complete all training assignments and maintain personal training records
Participate in and/or lead Non-Conformance Investigations
Complete Corrective and Preventive Actions (CAPAs)
Initiate, and follow through with actions required to close Change Controls
Participate in Internal, Customer and Regulatory Audits.
Assist with the training of new compounders
Perform start-up and shutdown procedures for all vessels
Minor repairs to the facility and equipment where applicable
Perform verification checks for equipment (scales, mixers, pH meters) used in manufacturing as per predefined time periods
May be required to assist Validation or Pharmaceutical Technology staff with new formulations and scale ups
May be required to assist with investigations where necessary
Notify compounding lead hand and mechanic in a timely manner if equipment parts and compounding consumables are low in quantity
Other duties as assigned.
Additional responsibility (Only applicable to customer facing roles)
Report any adverse event received from customers for company products to the pharmacovigilance department / Drug Safety on the same day or within 1 business day
Qualifications
University degree with 1-2 years of technical training experience
Post-Secondary education in scientific discipline is preferred or a minimum of 5 years experience in a pharmaceutical environment
Must possess the ability to function effectively in a team environment
Must be able to actively listen and receive coaching and applicable training
FL licence preferred
Excellent math skills
Proficient in MS Word, Excel, PowerPoint and Lotus Notes. Must be comfortable with use of tablets and trainable on associated programs (MES, SAP)
Excellent verbal communication skills for interacting with personnel on a daily basis
Previous experience in a pharmaceutical manufacturing environment
Issues that may arise that have a GMP impact are evaluated at the time of occurrence in conjunction with the supervisor and QA.
Working conditions
Overtime will be required to address priority items. This may be additional time during the work week and / or on weekends with last minute notice
Shift work required which may include weekends
Use of G.M.P garments and Safety Equipment (PPE) as required
Physical requirements
Physically fit, able to lift at least 25 kgs
Stand for long periods of time
Bending and squatting throughout the work day
Direct reports
NA
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
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