Senior Executive - Quality Control | Regulatory Affairs Officer (Male)
About the Employer
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 demands.
SENIOR EXECUTIVE - QUALITY CONTROL
- Establish a comprehensive NABL- accreditation 17025/2017-Quality Manual, Standard Operating Procedures (SOPs), and strict record-keeping.
- Maintain metrological traceability of measurement results and properly estimate measurement uncertainty.
- Successfully participate in at least one relevant PT program before gaining accreditation in each applied discipline.
- Perform routine analysis of raw materials, excipients, packing materials, water analysis and finished products.
- Preparation of COA and SPEC / STP SOP preparation.
- Knowledge of OOS / OOT / incident / deviation investigation procedure.
- Review of routine analysis data and stability data and SPEC and STP.
- Follow the test procedure as per QC compliance.
- Perform analytical method development and validation for drug products and preparation of AMV protocols and report.
- Analysis of formulation development trials, routine stability and drug excipient compatibility samples.
- Perform assay, related substances, dissolution test by HPLC and UV instrument.
- Execute HPLC & GC development.
- Execute water content, identification test by IR instrument.
- Review documents and release materials.
- Perform calibration of analytical instruments and stability sample analysis.
- Possessing knowledge in GLP & CGMP.
REGULATORY AFFAIRS OFFICER – (MALE)
- Coordination and submission of necessary documents / dossiers to the relevant authorities on time and maintain records of the same.
- Visit to all regulatory authorities and keep maintaining positive communications connected to the matters of all regulatory institutions (NMRA, SPMC, MSD, SPC Etc).
- Conduct periodic product evaluations to ensure that current practices are in line with all conformities.
Qualifications and Experience
- The applicant should be a registered Pharmacist in Sri Lanka Medical College.
- 01 year regulatory experience in Pharmaceutical industry.
- Ability work independently by meeting deadlines.
- Must be a good team player with positive attitudes.
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 [email protected] 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, Panita Piyaasa Road, Croos Watta, Ekala, Ja-Ela, Sri Lanka. Email: [email protected] Telephone: +94 11 2247996 / +94 11 2247998
