Planning and allocating work assignment Employed as a Compliance and Regulatory Affairs Officer at AndersonBrecon I am responsible for actively pursuing the streamlined introduction of new products within project timelines, setting up and maintaining Regulatory files, Preparation of annual Product Quality Reviews and general administrative duties. Task Recently AndersonBrecon UK was contracted to import and release a brand new medical product on behalf of a new client. I was tasked with the responsibility of ensuring that the project is managed and all of the regulatory documents are in place to allow us to release the product by February 2013. To list a few of my responsibilities; Implement new procedures, develop a process flow, write …show more content…
The short timeframe is the only likely constraint. Measurable – All tasks will be listed, allocated and assigned to the most appropriate person within the Quality department. Expected completion dates will be set, weekly progress meeting held to monitor the project and the associated tasks. The goal is to complete all the tasks by the 31 January 2013. Achievable – AndersonBrecon UK is a consulting services company which specialises in developing new products therefore it has all the relative resources to hand to ensure this is achievable. Relevant – Every task listed will need to be relevant to the task in hand. Due to tight time constraints any irrelevant tasks will result in wasted time. Timescale - It is imperative that all the regulatory documentation is received from the client and reviewed by AndersonBrecon’s quality department prior to the review of the three batch packaging and manufacturing records. Any delay here will have a knock on effect. QP services Tasks: Specific – The three batches will be imported from the USA to AndersonBrecon UK where it will be stored until satisfactory completion of Analytical testing and regulatory files in place. Once these tasks have been completed A Qualified Person (QP) will have to review and the release the batches before they can be placed on the European market. Measurable – All tasks that require QP input will be listed, allocated and assigned to the most appropriate person.
I am employed as a Maintenance Manager at the Strand Palace Hotel in London. I am responsible for the day to day maintenance of the whole building, also refurbishments of guest rooms and corridors, public areas and back of house areas. I am working with a team of 15 technicians and 4 shift engineers, all with different skills. Every first and last hour of my day will involve planning tasks to be completed, ranging from fixing any breakdowns of machinery to hanging a mirror in the admin office.
Primary area of responsibility was operating, maintaining and performing scheduled Preventative Maintenance tasks on over 60 assets in the Sterile Packaging Area. Ordered replacement spares for equipment through SAP system to dramatically reduce machine downtime. Documented failure and root cause analysis to determine PM frequencies. Administrator within our quality system database, Computerized Maintenance Management Software (CMMS) Infor EAM. Transferred over 8,000 assets from one database to another. Provided support to several departments for data entry of new assets. Scanning, copying, saving files to computer drives and inserting them into the data base on a daily basis. Inputted paper work sheets into database. Ensure accuracy and completeness of data entry by downloading records into Excel to verify completeness. Followed company Work Instructions and SOP's too fully comply with FDA regulations for Quality reporting. Work well and assist others from different departments.
Beginning on March 31st of this year, all refrigerated trucking companies are required to abide by the newest regulations handed down by the FDA for the safe transportation of food products. While some carriers may already be completely compliant, others may not be. It is vitally important that any carrier you do business with not only understands the regulations, but also does everything in their power to continue to be compliant. Not only does this protect the food supply from contamination, it also assures that your company does not suffer negative impacts due to improper storage and handling of food items.
He/she should maintain and updates reports related to the technical activities and analyze it to provide information to develop new procedures and protocols. He/She must provide training to the staff members, representing the company at various meetings, making presentations, and participating in the development of policies and regulations. Other responsible includes developing grant proposals, negotiating contracts, and monitoring the performance of the proposals. On top of developing, drafting, reviewing, and adapting permits to ensure regulatory compliance that involved in developing budgets, approving it and monitoring the expenditures associated with the
My comments are geared to help GFS resolve the issue with the customer. It will be my pleasure to try reach out to Russ regarding the latest concern and to further discuss while trying to obtain additional information to aid our team in their investigation. Unfortunately, since 2013 only 1 reported complaint from this customer has yielded a production date code to aid in our investigation. In that case, our team will pull production records for the last 14 days due to the short shelf-life to review.
Task-KSA analysis includes serval critical job tasks in the given work. We can use KSAOs to do these tasks (Truxillo, D. M., Bauer, T. N., & Erdogan, B. 2015). Task analysis plays an important role for many years, it’s hard to replace it (Brannick et al., 2007). Even though we can speculate KSAOs in the list of tasks, it’s common to find the explicit integration of KSAs in the process (Gatewood et al., 2011).
Some of these duties are to evaluate people, perform
The ICH Q7A, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (API), outlines the standards for the facility, utilities and equipment necessary to support a good manufacturing operation. This guide describes aspects related to all operations of receipt of materials, production, packaging, repackaging, labeling, relabeling, quality control, release,
The biggest challenge faced by a foreign company is that the local manufacturers will copy their product in a matter of weeks and mass-produce and distribute it throughout the country at a very cost effective rate. Another problem can be the strict rule of Chinese food and drug authority’s strict rule regarding the registration of devices.
Transition phases include development, manufacturing, awareness, readiness and implementation phases. This will be a huge endeavor as there are many pieces that need to come together and they manufacture millions of cans. Manufacturing plants will need to operate with Tetra Paks, distributor partners will need to be involved and end users in hospitals, nursing homes and home care settings will all need to be educated on the new packaging.
There is also a slight issue between consumer and manufacturer as both are in dis-agreement of keeping up with cool chain requirements. This is an operational issue as from an employer and employee perspective their always needs to be a good relationship between manufacture and consumer as the pharmaceutical products needs to have high level in security measures and the manufacturer intrusts the consumer with his products. This is related to another issue found with theft in organisation MISHAIR.
No batch of product can be released for sale or supply without the approval of QP (Qualified person).
The manufacture of medicinal products is subject to guidelines referred to as Good Manufacturing Practices (GMP). These help to ensure the quality, potency and identity of the product throughout all stages of manufacture to maximize the safety and therapeutic value to the patient. However to reach the consumer, the product must be distributed. Distribution includes the supply, export and holding of medicinal products in an ever more intricate web of relationships. Therefore it is appropriate that in order to maintain the level of assurance attained in GMP; the distribution network must also have its own guidelines known as Good Distribution Practices (GDP).
Tasks are communicative and usually authentic and they are meaningful and focus is on content.