Job Description
Sands Active (Pvt) Limited is (a subsidiary of Melwa Group) a BOI approved state of the art pharmaceutical manufacturing company by partnering with the State Pharmaceutical Manufacturing Corporation Sri Lanka with the intention to fulfill local pharmaceutical related demand
SENIOR EXECUTIVE - VALIDATION
Duties and responsibilities
- Responsible for the development and implementation of the strategies for the qualification of the manufacturing unit and equipment including compliance to GMP as per regulations.
- Responsible for review and approval of incidents, Change Control, CAPA, OOS and OOT, Market Complaints, etc.
- Responsible for commissioning, qualification and validation of plant and equipment, reviewing documentation and deliver best practices
- Review & approval of Process Validation Protocol & reports, Hold-Time Study Protocol & reports, Computer System Validation Protocol & reports, Cleaning Validation Protocol & reports, Transport Validation Protocol & reports and Aseptic Process Simulation protocol & reports.
- To conduct the self-inspection of different department as per schedule.
- Responsible to comply archival, retrieval and storage of documents.
- Review and approval of MFC, MPC, BMR, BPR and any other documents generated in R&D and production department.
- Ensuring overall quality compliance for the GMP activities carried out by different departments.
- Training Management through LMS for site and QA department
- Responsible for batch release of finished goods.
- Responsible for Vendor Audit.
- Carrying out Service supplier qualification.
- Review & Approval of Artworks
- Review and approval of COA, Specifications and Standard test procedures prepared by Analytical Development and Quality Control Departments.
- Review and approval of all department documents.
Qualifications and Experience
- Bsc or equivalent qualification.
- 05 years’ experience in validations activities from a leading pharmaceutical manufacturing company.
- Ability to work with minimum supervision.
- Excellent communication skills in English.
An attractive remuneration package inclusive of other fringe benefits and excellent career development opportunities await for the resourceful candidate.
If you feel that you are the right candidate that we are looking for, please send us your CV to info@sandsactive.lk including details of two non-related referees to reach us within 07 days of this advertisement.
Manager - HR & Administrations, Sands Active (Pvt) Limited, No 51, Pathumya Road, Croos Watta. Email: info@sandsactive.lk Telephone: +94 11 2247996 / +94 11 2247998