Compounder

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 SOP’s 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 (CAPA’s)

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 or equivalent 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

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

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, ethnic origin, citizenship, ancestry, sex, age, marital status, family status, physical or mental disability, gender identity, gender expression or any other ground protected by applicable human rights legislation.

#J-18808-Ljbffr