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 hr.corporate@pranayagroup.com,
or samhitha.hr@pranayagroup.com
No comments:
Post a Comment