Senior quality engineer and validation supervisor
Baxter international
Total years of experience :20 years, 3 Months
Part of my job responsibility's are:
1- Lead the validation activities as part of the facility design, build and qualification project by hands-on work and support from specialist contractor(s) as required.
2- Close liaison with the building contractors, engineers and vendors of facility and equipment items to ensure full and appropriate information is provided, along with vendor qualification protocols.
3- Prepare and execute the FATs, SATs, IQ/OQ as appropriate of plant and equipment, reviewing documentation and advising team members to deliver best practice.
4- Responsible for the oversight of ongoing (DQ, IQ, OQ, PQ) validation activities once production has commenced.
5- Review of vendor protocols and creation or approval of in-house protocols and reports to deliver a complete package of qualification documentation.
6- Maintain these relationships, monitoring KPIs so that performance and value for money is maintained.
7- Manage other validation team member(s), including their performance, development, training and compliance.
8- As a key member of the Quality team, contribute to the overall validation strategy for the site as well as act as a technical point of contact for internal and external stakeholders.
9- Key contributor in the project team to validate the manufacturing unit, working full-time on design, build and qualification activities.
10- Work effectively and supportively with other project team members to deliver the GMP manufacturing facility in accordance with the programe.
11- Draft and review GMP documentation including validation documentation, SOPs, and training documentation.
12- Train team members in procedures relating to validation as required.
14- Understand the production schedule, and work closely with Manufacturing and Engineering to build a qualification schedule.
15- Work in a safe manner, ensuring full compliance to HS&E policies.
16- Participate in and respond to external an internal audits
My main work area is Pharmaceutical Validation, calibration, lab service and qualifications.
My ambition is to continually develop my skills as a person and technically on different techniques. Be proactive in my daily work and to practice continuous improvement in providing fast and good quality customer service. Keep high integrity to build strong and confidence customer relations.
Specialties
HPLC, UPLC, LC-MS, LC-MS/MS, GC, GC-MS, ICP, ICP-MS, FT-IR, NIR, AAS, Sun Systems, Validation (For labs shipments and manufacturing machinery), and all lab equipment used in pharmaceutical laboratories.
All includes complete system installation, Installation Qualification and Operation Qualification - DQ/IQ/OQ/PQ services. Preventative maintenance, trouble shooting, repairs and technical support.
• Working with Chemical analyzers instruments (HPLC, GC, AAS, UV, UV-VIS, FT-IR, NIR, PH Meters, Ovens, Autoclaves, Stability Chambers, Incubators and DQ, IQ, OQ and PQ Qualification).
• I am responsible for the IQ, OQ and PQ for production lines, for Weighting Rooms, blending machines, blistering and capsuling machines, coating machines, granulating machines and packing machines.
• I am also responsible for the environment monitoring in plants, laboratories, stability areas and warehouses.
• Supervise, evaluate, develop, train and provide guidance to validation staff and provide timely and appropriate performance feedback.
• Assure that validation staff involved in validation activities are adequately trained on all applicable SOPs.
• Organize and plan validation schedules according to production planning.
• Write, review and approve validation protocols and final reports.
• Review and update validation master plans, as necessary.
• Provide Validation Manager with a list of validation projects completed during a specified reporting period and ensure that validation activities are performed in accordance to any regulatory guidelines or submissions.
• Assure full compliance with cGMP’s and other related requirements.
• Participate in Validation projects as required, including writing protocols, executing protocols, and writing final reports.
• Assist with development and monitoring of validation budget.
• Prepare periodic updates for upper management as to project status.
• Assist in auditing of internal and external processes, including serving as company representative during audits by various agencies.
• Make any task or having any responsibilities upon the direct manger orientations.
Service and installation, qualification and validation for analytical instruments
Service and installation, qualification and validation for analytical instruments
Hardware/software operator
Installing network and computer hardware and software configuration.