PRANAYA GROUP Urgent Requirement for QA QC Production R and D Departments Apply Now

PRANAYA GROUP Urgent Requirement for QA QC Production R and D Departments Apply Now

Greetings from Pranaya Group

We have an Urgent requirement for the following departments

Department: Quality Assurance (QA) (Injectable Experience)

Position: Manager       

Experience -10-12 years

Openings: 01                   

Location: Safe Parental, Narasaraopet, Guntur Dist, A.P.

Qualification: B.Pharm and M.Pharm-Pharmacy

Job Description: NOTE: Please Mention in Subject as “QA Manager”

  • Should be approved by USFDA /MHRA, should be handling ROW marketing etc,
  • determining, negotiating and agreeing on in-house quality procedures, standards and specifications
  • assessing customer requirements and ensuring that these are met
  • setting customer service standards
  • specifying quality requirements of raw materials with suppliers
  • investigating and setting standards for quality and health and safety
  • ensuring that manufacturing processes comply with standards at both national and international level
  • working with operating staff to establish procedures, standards, systems and procedures
  • writing management and technical reports and customers charters
  • determining training needs
  • acting as a catalyst for change and improvement in performance and quality
  • directing objectives to maximise profitability
  • recording, analysing and distributing statistical information
  • monitoring performance
  • supervising technical or laboratory staff.
  • Preparing of samples, Cultures & Media.
  • Has to perform Anti- Microbial Screening Methods, growth log reduction studies.
  • Assisting the Senior Microbiologists at lab requirements.
  • Candidate should good at handling of Microbiology Instruments.
  • Other works which are related to Microbiology Lab.

 

Department: Quality Assurance (QA) (Injectable Experience)

Position: Executive     

Experience: 02-05 years

Openings: 04                   

Location: Safe Parental, Narasaraopet, Guntur Dist, A.P.

Qualification: B.Pharm and M.Pharm-Pharmacy

Job Description: NOTE: Please Mention in Subject as “QA Executive”

  • Complete Experience in Quality Assurance of Pharma Manufacturing Injectable setup.
  • Responsible for Handling of Change control, Deviation, OOS, Market Complaint, Document Control, Equipment Qualification, process Validation, Cleaning Validation, Stability Study, Calibration of instrument, IPQA activity
  • Good knowledge of Various International Audit at Plant level.
  • Start to end process knowledge and understanding of QA profile.
  • Good in Team Handling and training.
  • Good communication skills
  • Flexible and capable of managing team
  • Should have good problem-solving skills and presence of mind.
  • Must be able to keep calm and make quick, clear decisions while coping with pressure
  • Understand the techniques and processes.
  • Regulatory knowledge & guidelines – GLP ,Schedule M, ICH, WHO TRS etc

Department: Quality Control (QC) (Injectable Experience)

Position: Manager       

Experience: 10-12 Years

Openings: 01                   

Location: Safe Parental, Narasaraopet, Guntur Dist, A.P.

Qualification: B.Pharm and M.Pharm-Pharmacy

Job Description: NOTE: Please Mention in Subject as “QC Manager”

  • Implementation of the GLP
  • Regulatory knowledge & guidelines – GLP, Schedule M, ICH, WHO TRS etc
  • Ability to maintain coordination with their internal and external stakeholder for their smooth and timely functioning & timely release of RM, PM, in-process, FG, & Stability samples.
  • Ensure compliance to perform the Preventive Maintenance/AMC of laboratory associated instruments /equipment.
  • Ensure scheduled preparation, review & approval of the SOPs, STPs, GTPs and analytical data sheets with respect to Quality control Lab.
  • To carry out the review and approval of qualification validation/Calibration data of the Quality control Instruments/equipment’s
  • To carry out the activities related to Quality Management System for new installation of the new instruments/equipment (i.e. Change Control Requests / protocols etc.)
  • To ensure cGMP & hygiene in laboratory. Reference Standard/ Working Standard management.
  • Ensure the continuous supply management of, Reagents/chemicals/Columns/solvents and glassware in the Lab.
  • Approval of analytical Data of Finished Goods, Stability, Raw materials, Packaging materials, Primary Standard and working standard.
  • Management and handling of stability studies.
  • Responsible for coordination with PPC for mfg plan & timely release/rejection.
  • Responsible for procurement of Lab equipment/instrument and it’s timely.
  • Qualification with complete documentation (i.e. URS, FRS, DQ, IQ, OQ, PQ)
  • Responsible for coordination with IT department to ensure timely execution of CSV.
  • Responsible for SAP, QM module application in QC.
  • Responsible to maintain safety in lab.

Desired Candidate Profile:

Candidates from Liquids /Dry Powder injection /Liquid injections (Ampoules/Vials)/ and LVP/SVP etc will be preferred.

 

Department: Production (Sterile Injectable)

Position: Chemist         

Experience: 02-05 years

Openings: 04                   

Location: Safe Parental, Narasaraopet, Guntur Dist, A.P.

Qualification: B. Pharm, B. Sc, Diploma & ITI.

Technical Skills: NOTE: Please Mention in Subject as “PROD Chemist”

Handling of Aseptic area, Sterile Manufacturing, CIP, SIP, Autoclave, Filtration, Dispensing, Vial /Ampoule washing, filling, visual inspection, Packing, BMR, BPR, SOP, Change Control, Deviation, Process & Cleaning Validation, Market Complaint, Media fill

Department: Quality Control (QC) – API

Position: Analyst/Chemist/Sr Chemist Experience: 2-5 Years

Openings: 05                   

Location: Safe Parental, Narasaraopet, Guntur Dist.

Qualification: M.Sc. in Analytical Chemistry/M. Sc Chemistry/B. Sc Chemistry

Job Description: NOTE: Please Mention in Subject as “QC Analyst/Chemist”

  1. Perform sampling of incoming raw materials for release testing.
  2. Perform tests and inspections on incoming raw materials, in-process materials and finished products in according with approved procedures and compendial monographs.
  3. Accurately document data and test results in appropriate logbooks, notebooks or result sheets.
  4. Assist in execution of IQ/OQ/PQ protocols for laboratory instruments.
  5. Write, review and update standard operating procedures at the direction of Management.
  6. Perform routine maintenance and calibration of lab equipment as needed.
  7. Review and check analytical data generated by other analysts.
  8. Follow standard operating procedures/stndard test methods when performing assigned tasks.
  9. Assist with compliance activities including investigation for Out of Specification (OOS) QC results
  10. Prepare samples and documentation for submission to external test laboratories.
  11. Assure accurate and timely input of QC data to information systems, databases and records.
  12. Other duties and responsibilities will be assigned as necessary

Candidate Profile:

  1. Working knowledge of wet chemistry and lab instrumentation.
  2. Strong attention to detail.
  3. Knowledge of cGMP regulations pertaining to laboratory.
  4. Readiness to work in shift, if required; and ability to work flexible hours to meet the demands of the business.
  5. Must be proficient with MS Office applications & Emails.
  6. Capable of maintaining clear and concise laboratory records.
  7. Must be proficient with Literature survey, library as well as internet.
  8. Strong oral/written communication skills.
  9. Ability to work well with and cooperate with others within the organization.

Department: Research & Development (R&D) -API

Position: Research Associate        

Experience: 2-5 Years

Openings: 05                                           

Location: Visakhapatnam

Qualification: M. Sc (Chemical Sciences) or M. Sc (Organic Chemistry)

Job Description: NOTE: Please Mention in Subject as “R&D -RA”

  • Perform synthetic chemistry reactions, reaction work-ups, purification of the compounds by column chromatography, crystallization, re-crystallization techniques, preparative TLC and operating lab equipment
  • Ensure that the samples generated during the course of synthesis are given for analysis and record subsequent results obtained and update the supervisor / group leader on the progress of synthesis and ensure samples are packed appropriately for shipment
  • Record the observations of experiment/reaction, results, utilization of resources and other activities related to the reaction in the laboratory or e-notebook following guidelines and in timely manner and ensure that the same is handled safely and confidentially.
  • Ensure that the instrument / equipments are calibrated, undergone preventive maintenance and are kept clean before use and in case of any breakdown, report to maintenance immediately
  • Ensure that they know the MSDS of the chemicals they are handling and aware of emergency response procedures in case of accidental spillage, leakage or fire and ensure proper waste segregation as per EHS norms
  • Attend all mandatory trainings and update training records as and when trainings are completed
  • Ensure confidentiality at all times
  • Prepare SOPs/IOPs/EOPs/OCPs when any new lab activity is identified or existing one requires updation
  • Any other lab responsibilities as indicated by the EHSQ team member/ supervisor / group leader.
  • Attend training on environment, health, and safety (EHS) measures imparted company
  • Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety

Technical/functional Skills:

  • Should be familiar with concepts of chemical synthesis
  • Familiar with operations of relevant apparatus – instrument / equipment.
  • Good Knowledge of analytical techniques and analytical data interpretation.
  • Good communication skills

Behavioural Skills:

  • Able to work follow instructions and perform the tasks under the supervision of the project leader
  • Fair interpersonal skills

Shortlisted candidates will have initial Telephonic interview.

Interested Candidates, please share us your updated profile (with Photo) along with CTC Letter to[email protected], or[email protected]

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