DNS Fine Chemicals Laboratories P Ltd

Badlapur East, Mumbai

Key Responsibilities:Implement and monitor QA systems (as per GMP/ISO/FDA guidelines).Conduct internal audits and support external audits (regulatory & client).Review and approve SOPs, batch records, and quality documents.Investigate and document deviations, CAPA, OOS, and change controls.Coordinate with production, QC, and regulatory teams for compliance.Ensure training and qualification of QA team members.Maintain records and documentation per regulatory standards.

QC: ManagerHandle deviations, market complaints, change control, OOSInstrument calibration as per SOPPerform Method ValidationDevising, improving, and reviewing the procedures for products or processes.Preparation of SOPs if any required. Keep SOPs updatedClearing internal and external auditsDocument preparation (as per customers requirement)Ensure all the work of department has been managed effectively.Oversees the collection and production of samples to evaluate quality.Interpret blueprints for the purpose of establishing customers critical needs and how they should be measured.Conduct routine and non-routine analyses of in-process materials, raw materials, environmental samples, finished goods, or stability samples.Perform the quality inspection process of new part samples and record the data.Check dimensions and surface quality of random batches of finished products to ensure they meet all company quality standards.Inspect all product returns, analyze the defect, and document the findings.Verify all processes are conforming to established quality standards and required customer specifications.Carries out ongoing lab and field sampling. Auditing visual, dimensional, and mechanical tests of materials and processes.Interpret test results, compare them to established specifications and control limits, and make recommendations on the appropriateness of data for release.Complete documentation needed to support testing procedures including data capture forms, equipment logbooks, or inventory forms.Investigate customer complaints regarding quality issues and develop a solution.Record, compile and prepare reports for analysis and evaluation.Assist in the development of needed records and standards and maintain accurate and detailed files as required.Instruct the method of disposition of discrepant material.Assist in designing and implementing the procedure for the use of Statistical Process Control across all departments as required.

Experience of minimum 2 yrs in Pharma Production.Performing Unit operations like - CF, Reactor, FBD and other production equipment's to manufacture APIs (Batch Process) in an FDA approved plant.Filling BMR/LMR/BPR, Logbook - OnlineCoordinating with QA and QC team for quality productionTechnical Support on the manufacturing processes, machine operation, record maintenanceTo work in GMP environment by following procedure/production operations as per SOPs.Comply to the regulatory requirements at each stage of activityOpening for Production Officer - Trainee (5 vacancies) - FreshersShould be open to work in rotational shifts - Day/Night Shifts (8hrs)Work Location: Badlapur, MIDCQualification: BPharm / MPharmPerforming Unit operations like - CF, Reactor, FBD and other production equipment's to manufacture APIs (Batch Process) in an FDA approved plant.Filling BMR/LMR/BPR, Logbook - OnlineCoordinating with QA and QC team for quality productionTechnical Support on the manufacturing processes, machine operation, record maintenanceTo work in GMP environment by following procedure/production operations as per SOPs.Comply to the regulatory requirements at each stage of activity