Quality ManagerPermanent LeicestershireThis position would suit a QA Manager or recent QP with a background within Quality Operations in the sterile or API manufacturing with...
Quality Compliance Manager
Attractive salary & package
Have you worked in a analytical and QA environment?Have you dealt with out of spec results, investigations and created corrective actions?Have you dealt with onsite compliance, regulatory and manufacturing?Also supervised or managed staff?
- Contribute to the compliant operation of the QC testing including stability program but not limited to attending project meetings as the QC Compliance Team representative; Providing Quality support to manage the laboratory compliance through, Risk assessment, monitoring Laboratory Quality Management System Performance and monitoring Data Integrity controls and Laboratory inspection readiness at site.
- Responsible for OOS (Out-of-specification)/OOT (Out-of-trend)/OOE (Out-of-expectation)/OOC (Out-of-calibration) investigation and management including; issuance; provide technical experience; judgement as called upon during investigations; provide written documented investigations in an appropriate and timely manner.
- Effectively communicate and deliver key business messages to superiors and/or peers in a timely manner.
- Develop metrics and other tools to measure QC Compliance and/or systems. Understand departmental KPIs and their impact on site targets.
- Act as an ambassador of QC Compliance by actively mentoring or coaching within the QC Organization.
- Provide proactiveness while dealing with equipment's/method's related troubleshooting problems and shows expertise to minimise the occurrences.
- Perform independent quality evaluation of deviation reports including root cause analysis cause/preventive action identification, CAPA effectiveness check and trending.
- Prepared slides and presentation related to month/quarterly QRM (Quality review management) showing incidents related to OOS/OOT/OOE related events, implementation and effectiveness of CAPA system.
- Liaise with QA inspector for on time submission of investigation reports, providing QC's feedback on queries raised and effectively dealing for on time closure of open investigations within strict compliance of in-house procedures.
- Provide training and support to the Quality Control group. Ensure staff is adequately trained to perform job assignments. Execute training in accordance with written procedure including but not limited to performing training assessments, documentation of training, and assisting in the preparation of training programs and curricula.
- Conduct risk assessments and gap analysis of the current quality systems and generate appropriate actions plans.
- Prepare and complete product quality reviews to ensure compliance with regulatory requirements and to identify areas for improvement.
- Ensure strict adherence to cross-functional department standard operating procedures, GMP compliant start-up.
- However, job responsibilities may not be limited up to above mentioned requirement but it will also cover below added responsibilities based upon business requirement.
- Participate in the internal audit program, revise and issuing the SOP's for QC department.
- Participate actively into stability data systems including; reviewing; approving stability protocols, reports and handle customer related stability management queries.
- Hosting internal/external inspections.
- Supervising/Managing compliance team.
- Degree or equivalent in science with analytical pharmaceutical or bio pharmaceutical industry experience.
- Significant Quality control product's in-process, release testing and cleaning validation/qualification.
- Experience of hosting regulatory/internal and external inspections.
- Experience of supervisory and managing.
- Experience of working within the Pharmaceutical GMP regulated industry.
- Knowledge of Quality Management Systems, including FDA compliance standards, cGMP regulations/guidelines.
- Knowledge of Change Control/Deviation management and CAPA identification/implementation.
- Proficient in Microsoft Word, Excel, Power Point.
- Ability to work and communicate with cross-functional teams, to work effectively with people at all levels in an organization
- Have strong attention to detail and excellent organization, with an ability to manage multiple priorities and re-prioritize tasks, as required.
- Excellent oral and written communication skills.
If you would like to apply for this position, please use the link provided. For more information regarding this position or any others, please call Bal on 0121 728 8455.