Dear Candidate:

Please read the job detail and answer the question seen below so that we can understand you and forward the CV along with your details to the client.


Duties & Responsibilities :
1.      To ensure that the action plan derived to achieve departmental goals and objectives are followed and implemented in timely manner.
2.      To ensure that production facilities are maintained as per GMP & EHS requirements.
3.      To provide training for GMP. EHS and SOP’s to production team and to ensure that the procedures are implemented and followed by employees.
4.      To identify the training need of employees and accordingly preparation of training matrix and to ensure training program and effectiveness of training.
5.      To ensure the EHS, QMS, Personnel & Hygiene and GMP followed by employees involved in manufacturing and to impart continual training for improvement.
6.      To ensure that Quality policy in understood by employees and implemented.
7.      Reviewing all manufacturing records to ensure the data integrity and GMP compliance.
8.      Preparing, reviewing the instruction for the production of intermediates or API’s according to written procedures.
9.      Making sure that all production deviations are reported, investigated, evaluated and necessary CAPA taken on timely basis in a scientific manner.
10.  To ensure that all equipments are qualified before use, preventive maintenance are carried out as per schedule and to ensure the measuring and monitoring devices calibrations are performed as per frequency.
11.  To identify the changes. Modification and up-gradation requirement and to propose changes in product, process or equipment.
12.  Preparation of SOP’s, BMR, Manuals, work instructions and other manufacturing related documents.
13.  To ensure the production and dispatch plan given by Production Manager completed and to report for any departure in schedule.
14.  Investigation of OOS, OOT, Deviation & other failure and to derive necessary CAPA and the follow up for compliance and effectiveness of CAPA.
15.  To carry out cross functional self-infection / internal audit as per SOP.
16.  Coordination with other departments for smooth functioning of department.
17.  Development and continuously improvement in process, quality and facility.
18.  Monitoring of daily plant activities and reporting to Production Manager.
19.  In absence of Production Manager responsible for overall manufacturing activities.    
20.  To Maintain GMP compliance and safety norms in manufacturing area all the time. To assist in audit processes, compliance and internal audit. To train subordinates & housekeeping personnel for BPRs/ SOP/GMP/safety/ housekeeping in . Manufacturing activities of API and its intermediate related to plant-3 (Production planning, Manpower planning, review of manufacturing documents) To supervise production batches as per Batch Production/Packaging Record (BPR). Various unit operations and unit process like distillation, filtration, drying, Milling, sifting, powder processing operation and packaging of API & intermediates To co-ordinate with QA/QC/ R&D for required GMP documentation of production activities in manufacturing area. To perform Laboratory Information system (LIMS) related activities (sample intimations and view results). To perform Quality Assurance Management System (QAMS) related activities. To perform Document Management System (DMS) related activities. Working in eBMR implementation project New Product introduction and Technology transfer in co-ordination with R&D. To assist for maintaining equipment performance and co-ordinate with Engineering Department for maintenance of equipment Assist and conduct self audit for manufacturing area. Compliance to the observations (if any) shall be done
21.  To perform manufacturing operations of API/ intermediate processes in the plant.
22.  To ensure manufacturing operations are continually supported and maintained in compliance with GMP, quality, safety and environmental regulations.
23.  Meeting all the delivery schedules for the products as committed in the Plan. Co-ordination with API Research team, Quality Assurance, Quality Control, Engineering and Warehouse functions to ensure compliance to the committed Plan.
24.  Support and maintain Equipment, Systems and Procedures related to manufacturing operations.
25.  Drive continuous improvement program for relevant product and business processes and projects.
26.  Ensures timely execution of Pre-validation and Validation batches and co-ordinates effectively with the Project/TSD team for the technology transfer of Products.
27.  Maintaining and up keeping the area as per the cGMP and · Regulatory requirements and putting continuous efforts for improvement in quality and Productivity.
Providing full support and cooperation during audits.

Required Key skills:  
·         confidence  
·         technical skills  
·         project management skills
·         organization and efficiency
·         leadership and interpersonal skills
·         problem solving skills
·         IT and numerical skills
·         communication skills
·         Team working skills.  
Managers must also be able to handle responsibility and the pressure of meeting deadlines.

Following machines Knowledge:
1.Reactor
2.centrifuge
3.Pressure Filter
4.Fluid Belt Dryer
5.Pusher Centrifuge
6.Blender
7.Pin mill

Experience:
10 to 15 Years.

Salary:-
As per industry Standards

Location: - MIDC Kurkumbh, Daundh, Pune

Qualification:-
B.Sc. (Chemistry)/ M.Sc.(Organic Chemistry)