Assistant Manager QC

Sangam Consultancy

Handled Qualification (IQ, OQ and PQ) and documentation activity of all QC instruments

 Leading a team of chemist, executive and senior excutiives (8 analyst) for testing of raw materials, in-process,

intermediates, and finished products (trial, validation and stability batches) using HPLC, GC and wet analysis

 Prepared all general, operational, and calibration standard operating procedures (SOPs) at QC and maintained good

QMS system

 Prepared Standard test procedures, specifications of raw materials, intermediates, finshed products as per tentative

specifications, STPs received from R&D

 Ensured timely sampling of raw materials (RMs) from warehouse, testing as per R&D soecification, preparation of

approved lebels, preparation of COAs and sharing to warehouse

 Ensured timely release of In-process, cleaning, intermediate and finished product results, preparartion of COA and

timely intimation to production

 Handled analytical method transfer activity of KSMs, intermediates and APIs of the oncology and non oncology

products from ARD (R&D) by both collaborative and non-collaborative methods.

 Ensured timely completion of method transfer protocol & report and its submission to QA

 Ensured calibration of all QC instruments within stipulated time as per the master calibration schedule

 Preparaion and timely storage of control samples of validation baches

 Preparation of stability protocol, and storing of validation batches under long term, intermediate and accelerated

stability conditions.

 Handled the disregard, incident, deviation, OOS, CAPA and change control activities at QC

 Coordinated with vendors (instrument, chemicals etc) and purchase dept. for timely indent and release of purchase

order

• Experience

  6 - 10 Years

• No. of Openings

  03

• Education

  B.Pharma, B.Sc, M.Pharma, M.Sc

• Role

  Assistant Manager QC

• Industry Type

  Manufacturing / Production / Quality

• Gender

  Male

• Job Country

  India

• Type of Job

  Full Time

• Work Location Type

  Work from Office