Sands Active (Pvt) Limited is (By Melwa Conglomerate) a BOI approved state of art Pharmaceutical manufacturing company by partnering with the State Pharmaceutical Corporation Sri Lanka with the intention to fulfill local pharmaceutical related demand.
VACANCIES
EXECUTIVE – QUALITY CONTROL
Duties and Responsibilities
•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 date & 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 trails, routine stability & 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 & stability sample analysis.
•Possessing knowledge in GLP & CGMP.
Qualifications and Experience
•BPharm/Bsc in Chemistry
•01-03 years’ experience in a pharmaceutical manufacturing QC lab or similar laboratory experience.
•Hands on Experience in Handling HPLC, GC.
•Expertise in Handling of KF instrument, IR, UV, Dissolution apparatus & chemical analysis.
•Work experience in a cGMP with a special emphasis on GDP (Good documentation Practice) Must have experience with NMRA, WHO and EU regulatory environment and Process.
EXECUTIVE – MICROBIOLOGY
Duties and Responsibilities
•Prepare microbiological media and reconciliation as per SOPs.
•Performing growth promotion test and periodic culture suspension.
•Performing microbiological tests and interpreting the results based upon the SOPs.
•Operation of autoclave sterilization, decontamination and disinfectant preparation with online documentation.
•Analysis and sampling of water samples, in process, raw materials and finished products. Perform equipment calibrations.
•Handling of OOS, Incidents, change controls, risk assessments and deviations.
•Preparation of trend and reports.
•Preparation and implementation of SOP, STP, specifications and protocols as per current GMP guidelines and pharmacopeias.
•Identify and implement process improvements as an effort to strengthen the quality system.
•Should trained on the following areas: environmental monitoring, sterility, MLT, bioburden/water testing, BET, and disinfectant efficacy, container closure studies, hold time studies, aseptic process simulation, area qualifications and other validation activities etc
Qualifications and Experience:
•Degree in Microbiology or equivalent.
•01-03 years’ experience in a pharmaceutical manufacturing microbiology lab or similar laboratory experience.
•Work experience in a CGMP regulated environment is preferred.
•Ability to work flexi hours, split shift and during weekends and holidays.
Manager-HR & Administrations,
Sands Active (Pvt) Limited,
No 51, Pathum Piyasa Road, Croos Watta, Ekala, Ja-Ela, Sri Lanka
Email: [email protected]
Telephone: +94 11 2247996/+94 11 2247998
An attractive remuneration package inclusive of other fringe benefits and excellent career development opportunities await for the selected candidates.
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 14 days of this advertisement.
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