Prepares and revises master batch records (MBRs) for manufacturing and packaging and provides input, support and assistance to the Technical Operations, Pharmaceutics & Process Technology (PPT) and Operations groups. Works with Engineering groups to maintain MBR templates. Leads and participates in improvement initiatives to support the site as well as improve processes within the Technical Writing department.
Master Batch Records (MBR) Generation
- Understands all requirements to generate and develop all master batch records working closely with commercial departments, Technical Project Managers and Business Managers in the generation and approval of Master Batch Records (MBR's).
- Updates and maintains master records and directories ensuring that records are updated as per current requirements.
- Follows production schedule requirements.
- Prepares planned deviations, execute action items to facilitate manufacturing and packaging activities.
- Develops packaging specifications for new PDS projects. Maintains files and distributes specifications to appropriate departments. Obtains new packaging codes.
- Verifies accuracy of bill of materials and item master information that has been entered into the computer system as it applies to both manufacturing and packaging components.
- Creates and ensures the most current approved Shipper Labels and Shelf Pack Labels are located in the ?master? directory. Generates and updates Shipper Fill Diagram and Pallet Pattern as per packaging instructions.
- Coordinates the official sign off circulation and implementation of Master Manufacturing and Packaging Records.
- Controls, compile and maintains Product Technical Files for all products.
- Controls access to MBR'S. Provide current Master Records to Planning and maintains the MBR data base.
- Generates and revises Change Control to master records and generation of new Master Records.
- Assists Technical Project Leaders in the generation of protocols, reports and assessments.
- May be essential to perform alternating or rotating shift work (as required)
College Diploma in Science/Technical related field (Food or Drug)
B.Sc. an asset.
Minimum of 1 year related experience with report writing and batch record preparation preferred.
Equivalent combinations of education, training, and relevant work experience may be considered.
Knowledge, Skills and Abilities:
Strong written and oral communication skills. Good technical skills and capability to understand different manufacturing and packaging processes. Well organized and detail oriented. Knowledge of Good Manufacturing Practices and ability to follow Standard Operating Procedures (SOPs). Ability to work under pressure and meet tight deadlines. Experience in managing multiple priorities. Self motivated and able to work independently. Proficiency using MS Office, particularly Microsoft Word and Excel. Proficiency with the English Language.
Put the Customer First
- Think and act with a customer-centric mindset to deliver exceptional customer experiences. Own Your Results
- Take personal accountability for all you do and always exercise good judgement. Find a Better Way Everyday
- Be intellectually curious and embrace Practical Process Improvement (PPI).