Drug QA Consultant
Drug QA Consultant
Location: Basingstoke
The role will provide supervision and management of the outsourced microbiology service; managing the day to day testing activities and ensuring the overall quality and compliance of the service and delivery of test data in a timely manner.
Scope, Roles & responsibilities
More specifically manage delivery of routine Microbiological testing and Qualification of microbial Robustness of products by:-
* Providing supervision and management of the CTG to enable the group to meet: Site and lab Health, Safety and Environment requirements, Operations and procedures that comply with the principles of Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP), high quality standardised methodology execution and implementation of change control requests, and timely delivery of routine testing data and reports
* Ensuring CTG are correctly qualified for the roles defined by managing the recruitment of appropriately qualified personnel for the roles, owning execution of training program and refresher training needs required to maintain high quality and delivery capacity of the service, and ensuring the CTG are fully aware of all information necessary to carry out the contracted operations correctly.
* Managing end to end data generation owning timely high quality data deliver from request to digital record approval.
* Providing communication and support timely investigation of all compliance findings, retests, and test deviation investigations. Collaborate with the Oversight Owner to ensure Micro results and investigative review processes are effective
* Owning laboratory aberrant result investigations
* Collaborating with Oversight Owner on GMP and Safety inspection findings and support execution of any resulting improvement programs
* Providing leadership. communication and management of any problems associated with work which might pose a hazard or impact quality
* Communicating and lead alignment with Oversight Owner on all work processes and priority management decisions
* Providing feedback on executional and technical method changes in timely manner.
* Identifying time and cost saving efficiencies and collaborate with the Oversight Owner to implement meaningful changes that do not compromise Safety and Quality
* Tracking, investigating and monitoring all compliance outages and corrective and preventative actions within the Microbiology laboratory e.g. method deviations, aberrant results for MDM and CT
* Supervising the day to day activities within the laboratory to ensure Good Laboratory Practice is met:
?? Equipment calibrations
?? Adherence to global/site methods and site SOPs
?? Consumable maintenance and rotation (First in First Out)
Expected professional Qualifications & Experience
* Qualified to degree level (ideally in microbiology or life sciences)
* Significant microbiology experience, preferably including broader industry experience
* Recent extensive experience in routine Microbial testing core methods and good manufacturing and laboratory practice
* Good knowledge of microbiological processes related to product development and quality controls
* Experience of service supervision and management
Skills & Competencies
* Skilled at supervision with strong 360 degree visions of issues.
* Strong Good Science aptitude and good practices focus.
* Excellent communication skills, both verbal and written, with a passion for accuracy and attention to detail.
* A proactive thinker who can anticipate future issues and propose pragmatic solutions.
* Excellent interpersonal skills - must be able to effectively interact with a diverse group of people from different functions, of different nationalities and at different levels within the company.
* Strong Analytical thinking and problem solving
* Good Computer literacy
Personal Attributes
* Strong communicator
* Commercial understanding of corporate and operational business issues.
* Strong intellectual curiosity.
* Openness to change and ability to think out of the box.
Adecco acts as an employment agency for permanent recruitment and an employment business for the supply of temporary workers. The Adecco Group UK & Ireland is an Equal Opportunities Employer.
By applying for this role your details will be submitted to Adecco. Our Candidate Privacy Information Statement explains how we will use your information - please copy and paste the following link in to your browser
Location: Basingstoke
The role will provide supervision and management of the outsourced microbiology service; managing the day to day testing activities and ensuring the overall quality and compliance of the service and delivery of test data in a timely manner.
Scope, Roles & responsibilities
More specifically manage delivery of routine Microbiological testing and Qualification of microbial Robustness of products by:-
* Providing supervision and management of the CTG to enable the group to meet: Site and lab Health, Safety and Environment requirements, Operations and procedures that comply with the principles of Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP), high quality standardised methodology execution and implementation of change control requests, and timely delivery of routine testing data and reports
* Ensuring CTG are correctly qualified for the roles defined by managing the recruitment of appropriately qualified personnel for the roles, owning execution of training program and refresher training needs required to maintain high quality and delivery capacity of the service, and ensuring the CTG are fully aware of all information necessary to carry out the contracted operations correctly.
* Managing end to end data generation owning timely high quality data deliver from request to digital record approval.
* Providing communication and support timely investigation of all compliance findings, retests, and test deviation investigations. Collaborate with the Oversight Owner to ensure Micro results and investigative review processes are effective
* Owning laboratory aberrant result investigations
* Collaborating with Oversight Owner on GMP and Safety inspection findings and support execution of any resulting improvement programs
* Providing leadership. communication and management of any problems associated with work which might pose a hazard or impact quality
* Communicating and lead alignment with Oversight Owner on all work processes and priority management decisions
* Providing feedback on executional and technical method changes in timely manner.
* Identifying time and cost saving efficiencies and collaborate with the Oversight Owner to implement meaningful changes that do not compromise Safety and Quality
* Tracking, investigating and monitoring all compliance outages and corrective and preventative actions within the Microbiology laboratory e.g. method deviations, aberrant results for MDM and CT
* Supervising the day to day activities within the laboratory to ensure Good Laboratory Practice is met:
?? Equipment calibrations
?? Adherence to global/site methods and site SOPs
?? Consumable maintenance and rotation (First in First Out)
Expected professional Qualifications & Experience
* Qualified to degree level (ideally in microbiology or life sciences)
* Significant microbiology experience, preferably including broader industry experience
* Recent extensive experience in routine Microbial testing core methods and good manufacturing and laboratory practice
* Good knowledge of microbiological processes related to product development and quality controls
* Experience of service supervision and management
Skills & Competencies
* Skilled at supervision with strong 360 degree visions of issues.
* Strong Good Science aptitude and good practices focus.
* Excellent communication skills, both verbal and written, with a passion for accuracy and attention to detail.
* A proactive thinker who can anticipate future issues and propose pragmatic solutions.
* Excellent interpersonal skills - must be able to effectively interact with a diverse group of people from different functions, of different nationalities and at different levels within the company.
* Strong Analytical thinking and problem solving
* Good Computer literacy
Personal Attributes
* Strong communicator
* Commercial understanding of corporate and operational business issues.
* Strong intellectual curiosity.
* Openness to change and ability to think out of the box.
Adecco acts as an employment agency for permanent recruitment and an employment business for the supply of temporary workers. The Adecco Group UK & Ireland is an Equal Opportunities Employer.
By applying for this role your details will be submitted to Adecco. Our Candidate Privacy Information Statement explains how we will use your information - please copy and paste the following link in to your browser