Home / Jobs / Pharma Job : Alidac Pharmaceuticals Hiring for CQA Compliance Position

Pharma Job : Alidac Pharmaceuticals Hiring for CQA Compliance Position

Alidac Pharmaceuticals Limited (Formerly Known as Zydus Bsv Pharma Pvt. Ltd.) is a wholly owned subsidiary of Cadila Healthcare Limited (Zydus Cadila) We are engaged in contract manufacturing & supply of Oncology Injectibles to Regulated Markets. Our USFDA & EU-GMP approved facility is located in PHARMEZ (Pharmaceuticals Special Economic Zone) near Ahmedabad. We have a dedicated facility for very niche segment of oncology injectibles with expertise in Liposomal technology & complex oncology injectibles. 5 products for USA are approved from our site including 1 NDA & 1 Para IV. 3 Products are approved in Germany. We manufacture 4 products that are first time in the world including 1 NCE.

Job Title – CQA Compliance

No.of.Posts – 1

Experience – 3 – 6 yrs

Location – Ahmedabad

Job Description:

1) Handling of Quality Management System (QMS) documents i.e. Change control forms (CCF), Incident report forms, Deviation control forms and CAPA (Corrective and preventive action) forms of production department as per respective SOPs.
2) Preparation, review and revision of SOPs of production department as per respective procedures. Review of applicable SOPs of other departments.
3) Preparation and revision of batch records (batch manufacturing records and batch packing records) of all drug products and other studies (if any) as per respective procedures.
4) Preparation and revision of batch manufacturing records of aseptic process simulation studies as per media fill planning.
5) Review of executed batch records of all drug products, aseptic process simulation studies and other studies (if any).
6) Review of all documents of production area like attachment/annexure of SOPs and forms like breakdown, deviation, incident, change control, etc in line of GDCP and regulatory requirement.
7) Preparation of Qualification documents like IQ, OQ, PQ of equipment/ instruments/ machines; PQ of area and compilation of data after execution.
8) Preparation of URS (User requirements specification) of equipment/ instrument and machine.
9) Review of Technology Transfer Documents (TTD) of all new drug product batches.
10) To ensure timely execution and supervision of activities in dispensing area, manufacturing area, washing & sterilization (Autoclave) area, vial washing & depyrogenation area, external vial washing area, visual inspection area, general production area and packaging area in product batches, aseptic process simulation studies and other studies.
11) To ensure timely execution and supervision of routine activities like area cleaning & sanitization, monitoring of temperature & humidity and scheduled activity like non viable particle count monitoring.
12) To ensure timely execution and supervision of qualification activities in dispensing area, manufacturing area, washing & sterilization (Autoclave) area, vial washing & depyrogenation area, external vial washing area, visual inspection area, general production area and packaging area along with their documentation.
13) To ensure timely execution and supervision of cleaning, operation, calibration, validation and maintenance activities of equipment/ instruments and machines located in dispensing area, manufacturing area, washing & sterilization (Autoclave) area, vial washing & depyrogenation area, external vial washing area, visual inspection area, general production area and packaging area.
14) To ensure timely execution of recording and documentation of batch records, attachments of SOPs and the activity related other documents as per good documentation control practices and regulatory requirements and to verify/review all the data and documentation of responsible area/ activities.
15) To implement SOPs with proper training to the personnel concerned for operation and cleaning of machine/area/system of dispensing area, manufacturing area, washing & sterilization (Autoclave) area, vial washing & depyrogenation area, external vial washing area, visual inspection area, general production area and packaging area.
16) To evaluate the batch processing in order to achieve higher output with higher batch yield.
17) To provide support for preparation of departmental budget for all consumables items.
18) To get trained for Production planning control, follow up of day to day activities and other management activities of the department.

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Desired Profile:

UG – B.Pharma – Pharmacy

PG – M.Pharma – Pharmacy

Click here to Apply Online

About Diluxi Arya

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