We are growing, grow with us!
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.
Senior Manager CSV
- Manage End to End Validation activities. Provide strategy for Validation for both product and process validation.
- Independently handle validation activity and lead Validation Team
- Set up and follow up of regular meetings with project team / client. Record the minutes in the proper way
- Assess and develop policy\procedure for R&D informatics department (CSV, Data Integrity and Digitization).
- Represent R&D informatics in internal and external audits.
- Perform in general project management activities (Project charter/monitoring/QC/issue management)
- Manage quality documents : Write/Review Procedure\ work practice\ Validation Plan /RTM / Test Plan/ Test Report / Validation Report.
- Conduct Testing activities as Test Team Leader or delegate responsible.
- Act as a SME for main regulation requirements covering the Computerized Systems Validation and or Qualification:
- Independently Manage contact and interact with clients and/or affiliates
- Identify non-compliance event / complaint management and CAPA implementation and FU.
- Seniority level : mid Senior
- Study level : Master / Bachelor (with equivalent experience)
·Knowledge of programming guidelines
- Knowledge about regulations in scope with Computerized systems :ICH-E6 (GCP)/FDA CFR 21 part 11 (Electronic Record/Electronic Signature) or CFR 210 & 211 for GMP, Ema Eudralex Volume 4 Appendix 11, ISO regulations 9001, 27001,
- Knowledge about Validation/Qualification guidelines
- GAMP 5, DevOps, or Scrum methodology
- Knowledge about Data Integrity : ALCOA / ALCOA +
- Experience in the domain : 8-12 years +
- Experienced in handling of Enterprise level application validation projects.
- Worked on ERP applications like QMS, DMS and latest technologies like AI and ML.
- Experience in leading and managing complex projects
- Analytical and problem solving
- Autonomous, concentrated and high-quality work
- Ability to work in a team
- Sense of responsibility
- Very good command of English
- Quality Minded
- Good organization in document and good knowledge about office tools
If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.
For further information please don’t hesitate to contact us:
Ms. Vineeta Bisht
Manager, Human Resources India