Quality Control Associate/Jr. Officer/Officer/Executive/Sr. Executive
Lupin is one of India’s leading pharmaceutical companies that specializes in the manufacturing and sale of bulk actives and formulations. Some of the key products manufactured by Lupin Limited include Rifampicin, Pyrazinamide, Ethambutol (anti-TB), Cephalosporins (anti-infectives), and cardiovascular drugs.
Apart from these products, Lupin Limited also has expertise in the field of phytomedicines. Phytomedicines are medicines that are made from plant and herbal resources and are supported by modern medical research. Lupin Limited’s competencies in this area suggest that it has been able to develop formulations that are based on traditional medicinal knowledge and are supported by modern scientific research.
Job Title: Quality Control Associate/Jr. Officer/Officer/Executive/Sr. Executive
Department: Quality Control
Qualification: B.Sc, B.Pharm, M.Sc
- Conducting quality control analysis of raw materials, intermediates, and finished products
- Preparing and reviewing quality control reports and documentation
- Conducting laboratory tests and analyses in compliance with cGMP and SOPs
- Investigating and resolving quality issues, deviations, and non-conformances
- Maintaining and calibrating laboratory equipment and instrumentation
- Participating in internal and external audits and inspections
- Ensuring compliance with regulatory requirements and guidelines
- Providing technical support and training to team members as required
- Contributing to the development and improvement of quality control procedures and processes
- B.Sc, B.Pharm, or M.Sc in Chemistry, Pharmaceutical Sciences, or a related field
- Strong knowledge of cGMP, SOPs, and regulatory requirements
- Strong analytical and problem-solving skills
- Strong attention to detail and accuracy
- Excellent communication and interpersonal skills
- Ability to work independently and as part of a team
- Ability to prioritize tasks and meet deadlines
- Proficiency in Microsoft Office applications
The job description involves handling and calibration of various scientific instruments such as High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Ultraviolet (UV) and Infrared (IR) spectrophotometers, Surface Area and Pore Size Analyzer (SOR), Malvern-2000/3000, Karl Fischer Titration (KF), Potentiometric Titrators and Dissolution apparatus.
As an instrument specialist, the responsibilities will include:
- Handling and maintaining scientific instruments to ensure their proper functioning.
- Conducting regular calibration of instruments to maintain their accuracy and precision.
- Troubleshooting and repairing any instrument malfunctions or failures.
- Maintaining an inventory of supplies and reagents necessary for instrument operation.
- Collaborating with other members of the laboratory to ensure efficient use of instruments and to troubleshoot any issues that may arise.
- Ensuring adherence to standard operating procedures and safety protocols while handling instruments.
- Recording and analyzing instrument data, and presenting findings to laboratory management.
- Maintaining accurate records of instrument calibration, maintenance, and repair.
- Staying up-to-date with new instruments and technologies and attending training sessions as required.
Overall, the position requires a high degree of technical expertise, attention to detail, and strong problem-solving skills. The specialist must be able to work effectively as part of a team and communicate clearly and effectively with colleagues at all levels.
OSD (Oral Solid Dosage) Testing:
- Appearance testing: This includes visual inspection of the tablet or capsule for any physical defects such as cracks, chips, or discoloration.
- Dissolution testing: This involves determining the rate and extent to which the active pharmaceutical ingredient (API) is released from the dosage form.
- Disintegration testing: This involves measuring the time taken for a tablet or capsule to disintegrate into smaller particles in simulated gastric or intestinal fluid.
- Hardness testing: This involves measuring the crushing strength of a tablet using a tablet hardness tester.
- Friability testing: This involves measuring the ability of a tablet to withstand abrasion or breakage during handling.
- Assay testing: This involves determining the amount of active pharmaceutical ingredient (API) present in a tablet or capsule.
Dry Suspension Formulation Testing:
- Particle size analysis: This involves measuring the size distribution of particles in the dry suspension to ensure consistency and stability.
- Reconstitution testing: This involves assessing the ease of reconstitution of the dry suspension into a liquid form, as well as its stability and consistency.
- Homogeneity testing: This involves ensuring that the dry suspension is uniformly mixed, and that the concentration of the API is consistent throughout the suspension.
- Viscosity testing: This involves measuring the thickness and flow properties of the liquid suspension.
- Identification testing: This involves verifying the identity of the active pharmaceutical ingredient (API) using various analytical techniques such as chromatography or spectroscopy.
- Purity testing: This involves determining the purity of the API, including any impurities or contaminants that may be present.
- Potency testing: This involves measuring the strength of the API and ensuring that it meets the specifications listed in the monograph or certificate of analysis.
- Stability testing: This involves assessing the stability of the API under various environmental conditions such as temperature, humidity, and light exposure.
To apply for this job please visit pharmaceuticalcarrier.com.