Job Description

1. Job Description for Research Associate

Required Experience : 2 years

Preference : Male candidate

Education Qualification : M.Pharm. (Pharmaceutics)

Job Profile :

  • Candidate should have experience in NDDS Product Development of Parenteral, DPI forms for Regulated and Domestic Markets
  • Execution of Scale-up and Clinical Trial Batches for NDDS projects. Candidate should be competent for troubleshooting of the allotted projects
  • Responsible for exhibit / validation batches in co-ordination with process development lab
  • Should care for documentation and compilation of necessary regulatory submission data
  • Should have experience in technology transfer from R&D to manufacturing site
  • Monitoring stability of products during development and validation batches
  • Should co-ordinate with various functions like Analytical, QA, PDL & Plant etc.

 

2. Job Description for Officer / Sr. Officer / Executive-Quality Control

Required Experience : 1 to 5 years

 Preference : Male candidate

Education Qualification : M.Sc. / B.Sc. / B.Pharm.

Job Profile :

  • Should be well-versed with operation of sophisticated instruments like HPLC, GC, TOC & UV Spectrophotometer
  • Should possess knowledge of GLP, GDP and various regulatory procedures
  • To perform method validation / method transfer
  • Knowledge of CBO/ MARG will be an added advantage.
  • RM/SF & FG analysis as per the specification.
  • PPM & SPM testing.
  • Water Analysis.
  • Preparation and updation of SOP and STP.

 

 3. Manager QC

Required Experience : 8 to 10 years

Education Qualification : M.Sc. / B.Sc. / B.Pharm.

Job Profile :

  • Basic knowledge of Chemical & Instrumentation with FDA Approval in Micro section.
  • Have exposure to micro functions, testing, analysis, sterility, microbial, BET, Environmental Monitoring, Water sampling and analysis.
  • To maintain Good Laboratory Practices in the laboratory and to upkeep the Laboratory.
  • Responsible to plan for analysis of starting materials, services and utilities including water systems (Water for Injection, Purified Water, Pure steam condensate and Potable Water).
  • Responsible for review of SOPs and ensure SOPs for area under control are valid and meet all regulatory and QMS requirements.
  • investigate the OOS and Excursions results during environmental monitoring, water testing, Sterility tests and other microbiological testing.
  • Sterility Test, Bacterial Endotoxin Test, Microbial Limit Test, Growth promotion test, Environmental Monitoring, Isolation and identification of In house isolates,
    Preservation and maintenance of cultures, Preservative Efficacy test
    Nonroutine and routine validations (Hold time study, Shelf life Study, Autoclave validation, Media Fill validation etc. )

 

 4. Production manager

Required Experience : 8 to 10 years

Education Qualification : M.Sc. / B.Sc. / B.Pharm.

Job Profile :

  • The candidate should have FDA Certificate.
  • Should have excellent experience in Pharma Production, CGMP guidelines.
  • Experience in handling entire production unit right from Planning to Execution.
  • Accountable for production, productivity, quality of our process & products.
  • Monitor, control and correct all critical parameters at all stages of production.
    Ensure proper utilization of resources.
  • Monitoring of general hygiene of persons working in sterile block and cleanliness of the area.
  • Checking and monitoring of the manufacturing activities of batch preparation area. To ensure that products are produced and stored accordingly to the appropriate documentation.
  • To prepare and review the instructions relating to production operation and ensure their strictly implementation.
  • To ensure that production records are evaluated and signed by authorized person before they are sent to QA Department.
  • To evaluate proposed changes in product , process or equipment and ensure that appropriate validations are done.
  • To assist in the investigation of batch failures , Preparation of risk assessment, market complaints and product recalls.
  • To ensure that the required initial and continues training of concern personnel are carried out.
  • To ensure accurate monthly planner for 3 shifts including manpower as per the market demands and necessary plans are available to related departments..

 

 5. Officer/Executive/Sr.Executive-Production

Required experience : 3 to 5 years

Education Qualification : M.Sc. / B.Sc. / B.Pharm.

Job Profile :

  • To follow all rules and regulations of the Injection Department.
  •  To participate in all in-house training as arranged by the Company.
  •  To execute day-wise/shift-wise allocated work as per plan to ensure
    adherence to production schedule and document the same (including online documentation).
  •  To monitor the activities like RM Dispensing, operation and cleaning of manufacturing tanks, compounding isolator, vial washing, bung processor, tunnel, vial filling, vial sealing, external vial washing, linen washing and linen drying machine as and when required.
  •  To report any non conformities to Production Manager.
  •  Preparation of New SOP and revision of existing SOPs as and when required.
  •  Review documentation of all activities to ensure compliance to the process for future reference.
  •  Ensure that all the in-process checks are carried out and quality of the product is ensured at each stage as per the Standard Operating Procedures.
  • Communicate any equipment breakdown to maintenance team without any delay including monitoring the status and type of breakdown.
  • Maintain GMP standards at shop floor and conditions suitable for production of quality products as per requirement.
  •  To monitor the disinfectant preparation and filtration activity as and when required.
  •  Fill up batch manufacturing records and log books by following good documentation practices.
  • Follow-up of manufacturing activity as per standard operating procedures and batch manufacturing records.
  • Co-ordinate with Stores, Quality Assurance, Quality Control, Engineering & Packing departments for day to day activities.
  • Raise the incidents/deviations/change control to Quality Assurance.
  • Online monitoring of environment conditions in the process area and other area as defined by SOP (including necessary escalations in case of observed abnormalities).
  • To ensure Calibration and verification of the equipment, instruments and balances used in the production area.
  •  To co-ordinate for line clearance activities.
  •  To carry out error free documentation of the production activities.
  •  Coordinate with maintenance teams for planning preventive maintenance activities in order to resolve all machine related issues.
  •  Manage manpower effectively.
  •  Participate as a team member during audits.
  •  To carry out any other task and assignment as deemed appropriate by Production Manager.

 

 6. Sr.Executive/Executive-CQA

Education Qualification : MSc/ B.Pharm/ M.Pharm  
3+ years of work experience in QA, QC in OSD formulations business.

Job Profile :

  • Must have QA experience in various formulations like tablets, capsules, liquid orals, ointments &
    creams etc.
  • QA experience in sterile/ parenteral products essential.
  • Exposure to deal with FDA and well versed with D&C Rules & Act, WHO GMP requirements, ICH guidelines
    etc.
  • Exposusre to international regulatory audits is essential.
  • Must be well versed with quality management system such as Change management, Deviation management,
    OOS, OOT
  • Handling product complaints & recalls etc.
  • Exposure to RM PM vendor audits and C&FA audits and CBO is desirable

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