- Experience Level
- Experienced (non-manager)
Leading international Pharmaceutical Manufacturer seeks experienced QC Release Officers, working on a Double Day Shift rota 7am till 3pm one week followed by 3pm till 11pm the following week.
About the role:
Reporting to the QC and Product Release Manager and to the Senior QC Release officer for day to day operational duties, the QC Release Officer is responsible for performing all necessary duties to comply with the quality system in place in accordance with cGMP and ISO standards. Ensuring the review of all batch documentation and subsequent product disposition is performed to comply with internal Standard Operating Procedures in accordance with the UK Quality System. Work in conjunction with production to ensure compliance status is maintained within the facility.
Duties may include:
- Review of all pertinent batch documentation (including batch worksheets), as part of the product release process, in order to assess whether a product is compliant with a given specification and thus suitable for use ('fit-for-purpose' with regards to quality, safety and efficacy). Consideration must be given to any non-conformity raised during manufacturing
- Approval of individual batches for release to market or further internal use, once satisfied given specification has been complied with and all non-conformities have been considered with no impact on product quality.
- Support investigations of non-conformities that may impact upon the release process, product quality or compliance of the ASU facility to ensure manufactured products are compliant with specifications and suitable for its intended purpose.
- Support and lead the QC checker during normal shift operations to aid with resolution of any quality concerns.
- Contribute to the continuous improvement of all aspects of the quality system to ensure departmental objectives are met and compliance with regulatory requirements is consistently achieved for the ASU.
- Compilation of Certificates of Conformance as required to fulfil responsibilities to its customers.
- Operation of the Quality Assurance databases to support QA in publishing appropriate trends (e.g. KPI's) within the business.
- Where necessary, interfacing with other departments including attendance at meetings to ensure that the requirements of the QMS are met.
- Within the quality control and quality assurance team framework, to conduct additional duties as required to support colleagues in the effective execution of their duties.
- Ensure outsourced products are processed in a timely manner and made available for use with transactions performed on SAP (systems applications processes -stock management) updating status as required.
- The role holder must comply with policies or procedures relating to data privacy or information security.
- Participate in providing GMP training and coaching to staff.
- Support to the validation teams to ensure the principles of GMP are applied during validation activities.
- Generate and review departmental Standard Operating Procedures and associated worksheets.
- Perform the duties of QC checker when required.
- Deputise for the Senior QC Release Officer in day to day activities, when required.
Skills and experience:
- Minimum of a Degree in a life science subject or appropriate experience of working in a quality assurance or control related function within either the pharmaceutical/ healthcare related industry for at least 5 years or within a relevant aseptic compounding industry for 3 years.
- Experience of aseptic operations is necessary; if possible aided by experience in aseptic compounding activities.
- Very good knowledge of GMP requirements specifically for manufacturing and control of aseptically produced products as laid down in the Orange Guide.
- Product knowledge.
- Attention to detail
- A demonstrable ability to communicate effectively, both verbally and in writing
- Organised and methodical work style
- Capability of leading small teams
- Computer literacy, competency in using Microsoft Office computerised systems and experience of using spreadsheets