Role & responsibilities Should able to handle HPLC & GC,PH Meter, Knowledge on GMP&GLP Preferred candidate profile Familiarity with analytical testing techniques using HPLC/GC/FTIR/Dissolution/UV. Performing calibration of instrumentations Testing of finished product, raw materials, packaging and stability Perform analytical testing - HPLC, FTIR, UV

API -QA

Role & responsibilities Operation of all production equipments, execution and monitoring the process as per BMR during shift hours. To perform all the calibration activities for W.B and holding tanks receivers as per SOP and maintain calibration records as updated. To monitor overall plant parameters & utilities. To control the spills, salvaging of spills in the plant. To ensure personal hygiene inside the plant. To ensure all the chemicals are handled as per MSDS. Ensure to maintain online documentation in plants with respect to BMR, cleaning records, all production related log books.

Role & responsibilities Follow & Implement the GMP, Safety norms and adhere to company's policy Ensure compliance to safety standards, cGMP, good engineering practices and regulatory requirements Preparation and review of Equipment and Systems qualification Make design specification and ensure completion of qualifications. DQ, IQ, OQ. Authorized to prepare and verify Department documents. New equipment installation, commissioning of system's(Utility's) as applicable Operation and Maintenance of HVAC systems To ensure proper operation and monitoring of water systems, potable and purified water systems To ensure proper operation and maintenance of chillers, nitrogen plants, air compressors, driers, cooling towers, boiler, thermic fluid system & pumps Responsible for validating the HVAC, Nitrogen and Compressed air by coordination with external agency Verification of Preventive maintenance, calibration schedules and activities Responsible for facing internal, customer and regulatory audits Preparation and review of SOP's and Formats. Handling of CCF's, deviations coordinate with Quality Assurance and Concerned departments

Role & responsibilities Preparation and review of standard operating procedure. Monitoring of trend in the process and in the quality control. Preparation of Annual product quality review (APQR). Preparation of validation protocol & report. Reviewing of equipment qualification. To support the customer / regulatory audits. Follow up of CAPA. Handling of customer complaints. To support the preparation of new drugs endorsement / manufacturing license documents. Reviewing of stability data and monitoring of trend. Upkeep of documentation. Issue and control of documents. Issue batch production record. Issue and Retrieval of cleaning records. Review of batch production and equipment cleaning records. Documentation systems issue and control of documents. Upkeep of documentation. Issue of certificates photocopies to the user departments, with draw of obsolete copies and issue of uncontrolled copies whenever required. Checking the certificate of analysis prepared by quality control.

Role & responsibilities Audit Trail Review Batch Release Method Validation & Transfer Review Calibration Records Review Analytical Raw Data Issuance OOS, Lab Deviation CAPA QC Review Experience in handling audits Preferred candidate profile Should have participated in Audits and exposure towards it Should be qualified in Chemistry knowledge in process and production Smart enough to understand the regulatory requirements Knowledge in regulatory and GMP. Perks and benefits As per Company norms

Role & responsibilities Operation of all production equipments, execution and monitoring the process as per BMR during shift hours. To perform all the calibration activities for W.B and holding tanks receivers as per SOP and maintain calibration records as updated. To monitor overall plant parameters & utilities. To control the spills, salvaging of spills in the plant. To ensure personal hygiene inside the plant. To ensure all the chemicals are handled as per MSDS. Ensure to maintain documentation in plants with respect to BMR, cleaning records, all production related log books.