The nature of the position will be that of a primary resource for the development, execution, review and approval of equipment and software validations, including: computerized laboratory systems, system life cycle documentation (covering validation plans, design specifications, requirement specifications, etc.), change controls and decommissioning reports in accordance with 21 CFR Pt. 11 and GAMP5.
- Monitor equipment and software processes for adherence to established procedures and regulatory compliance.
- Provide guidance for equipment and software-related issues.
- Write, execute, review, or approve equipment and software validations (IQ, OQ, PQ).
- Write, execute, review, or approve change controls.
- Write, review, or approve periodic reviews.
- Stay current with changes to GXP, including FDA and EU and other regulatory bodies as well as guidance documents (i.e.: ICH, ISPE, GAMP, ISO, etc.).
- Interact frequently with laboratory/manufacturing/facility/Quality staff to provide expertise on equipment/software validations. Address conditions/practices with appropriate personnel, reports findings to QA Management.
- Issues, reviews, or approves document change requests.
- Participate in process improvement initiatives, and project teams.
- Performs other duties as required.
Skills and Requirements:
- Knowledge of 21 CFR Part 11 and ISPE GAMP5 required.
- Knowledge of cGMP requirements, PTC guidelines and ISO17205 is strongly preferred.
- Ability to accomplish the described duties using appropriate computer equipment and software (Microsoft Word, Excel, and Access).
- Ability to accurately and reproducibly perform arithmetic, algebraic and geometric calculations.
- Ability to record data accurately and legibly.
- Ability to use judgment as dictated by the complexity of the situation.
- Ability to understand and follow verbal or demonstrated instructions.
- Ability to work effectively as part of a team and to exhibit effective interpersonal skills.
- Ability to receive, comprehend and to effectively communicate detailed information through verbal and written communication.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Hannah Cihlar at (+1) 267 983 0133
or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.