"• Responsible For rDNA manufacturing and Parenteral mfg activities at Dholka premises • To ensure personal hygiene of the workmen before entering to aseptic area and maintain record. • To check and ensure that aseptic area workmen are following entry exist procedure properly. • To check and ensure that differential pressure, RH and temperature of the aseptic area and mfg area are within limit and record it properly. • To check and ensure that differential pressure of all Laminar Air Flow are within limit and record it properly. • To check on line in process parameters like temperature, RH, fill volume, quality of sealing at specific interval as mentioned in respective MMDI and SOPs and record the same in BMR • To do compounding activities and dispensing activities. • To check the vial washing machine, vial dehydrogenation tunnel, vial filling machine, vial sealing machine operation. • To check the autoclave and automatic vial Inspection machine operation. • To maintain equipment logs as per SOP • To ensure proper inter personal relationships (IPR) in the section. • To review daily production and to discuss other issues. • To ensure proper cleaning of the mfg areas. • To ensure proper status labeling as per Sop. • To ensure the all required documents to comply cGMP. • To ensure calibration certificates of all measuring instruments comply with norms. • To ensure concurrent documentation of all production processes undertaken. • To ensure plant wide cGMP compliance."
