Axelia Laboratories

The wheel is churning as India ascends to new heights. Happy Independence Day everyone!!

Celebrating 75 years of Indian Independence.
Azadi Ka Amrit Mahotsav.
Wishing everyone a Happy Independence Day this 15th of August!

Ode to our production team!

Working of Fluid Bed Dryer : Dry hot air is introduced at high pressure through a perforated bed of moist solid powder. The wet solids are lifted and suspended in the air stream to form a fluidized state of the solids. This results in effective & efficient drying of the granules.

FDA approved Chemist for manufacturing of External preparations (Creams, Ointments & Gels). Having minimum of 5 years of experience in manufacturing various external formulations.

Quality Assurance Executive for day to day workfloor QA activities and paperwork. Candidate with atleast 1 yr experience in QA and with good knowledge of basic pharma QA concepts.

Oral Liquid manufacturing line : Visual inspection & bottle labeling.

Job Profile :

Responsible for the day to day manufacturing, maintenance, packing & documentation activities of the respective departments ie: Tablet/Capsule/Oral Liquid/External Dept.

Operate Manufacturing machines, equipment and instruments. Perform scheduled cleaning & preventive maintenance of all equipment.

Handling of area and equipment qualification.

Perform line clearance activities and inform QA.

Formulation development.

Preparation & timely maintenance of MFR, BMR & BPR.

Validation of processes with coordination with QA department.

Review and updation of SOP.

Calibration & Validation of instruments & equipment.

Co-ordination with Stores, QC & QA departments for smooth day to day production activity.

Issue material requisitions as per MFR and request the same as per the requirement.

Receive material indent from stores & control over raw material usage.

Taking care of test samples, test request and supervision of operators.

Provide training on manufacturing processes & GMP for internal training.

Presentation of manufacturing activities and processes to internal & external auditors.

Attend the queries related to manufacturing activities during audits.

Initiate the change control, Deviation, CAPA in coordination with QA department.

Academic credentials : B.Pharm or higher. Computer Literacy is required.

Work Experience : 1-5 years experience in pharmaceutical formulations manufacturing preferred.
Manufacturing Approval from FDA will be given weightage.
Freshers may also apply for internship.

Personal Characteristics : Knowledgeable. Team person. Good communication skills. Fast learner. Systematic & well organised.

Job Profile :

Responsible for ensuring that the quality of drugs being manufactured meet prescribed quality levels.
Handle daily scheduled IPQA functions.
Co-ordination with production department for smooth day to day production activity.
Providing line clearance to production departments.
Perform RM & PM vendor audits.
Control functions of Sampling & Analysis of RM, PM, in process & FG as required.
Maintenance and control of stability testing of samples.
Documentation Control, Issuance & Conformance.
Maintenance & Review of SOPs, forms and related log books (physical & online).
Preparation & Revision of SMF.
Preparation & Revision of Validation master plan.
Preparation & Revision of Validation protocol, validation report, annual calibration/validation plan, etc.
Qualify new equipment, existing equipment.
Coordination with relevant departments for validation, production activities.
Preparation & Revision of BMR/BPR
Final review of BMR/BPR/FP COA. Issue batch release.
Verify the calibration and maintenance of instruments / Equipment. Checking of calibration/Validation certificate received by external party. Checking of In-house calibration certificate of Instruments.
Handle FDA processes as per D&C Act, Sched. M – c GMP, WHO GMP, ICH guidelines etc.
Handle international regulatory audits. Resolution of query of regulatory agency or various visitors / auditors.
Implementation of Change Control, Deviation management ie: OOS, OOE, OOT, Product complaints, Product recalls etc.
Preparation and Implementation of CAPA.
Prepare annual internal audit calendar, perform internal self-audits & implement necessary changes as per c GMP.
Prepare annual training calendar, impart training to new employee, impart internal quality system training & implement scheduled training of all staff.
Prepare audit report to adhere with regulatory guidelines, inspections & written procedures.
Archiving and maintaining all documents received from various departments.
Maintain original documents and its distribution records.

Academic credentials : B.Pharm or B.Sc (Chemistry, Micro, Biotech) or higher.
Computer Literacy is required. Fluency in English.

Work Experience : 1-3 years experience in pharmaceutical formulations quality assurance will be given weightage. QA experience preferred in the field of manufacturing formulations like tablets, capsules, dry powders, liquid orals, ointments and creams.

Freshers without work experience, must be knowledgeable & have clarity about the fundamentals of the above subjects.

Personal Characteristics : Knowledgeable. Confident. Team person. Good communication skills. Good presentation skills. Systematic analytical reasoning skills. Fast learner. Leadership skills.