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