CAREER OPPORTUNITY
LOOKING FOR PEOPLE WITH RARE DEDICATION
SKYBIOTECH LIFE SCIENCES (P) Ltd. is a research based pharmaceutical company unlike any other. Skybiotech Life Sciences is a company dedicated to meeting the unmet needs of the people with diseases. Meeting these needs, requires a vast and diverse skill set – from scientific research to public advocacy. If you have the rare dedication to join our team, we want to hear from you.
A MESSAGE FROM OUR FOUNDER
At Skybiotech Life Sciences we believe that life is a gift. It must be treasured and protected in every possible way. Hence we have dedicated our individual skills, knowledge – indeed our entire organization – to meeting the unmet needs of people with rare diseases. Everyone working here appreciates the importance of bringing innovative, life – improving therapies to the patients – regardless of the rareness of the condition or disease.
In short, we believe that people cannot be quantified. Perhaps not ironically, this credo of patient’s health before profits has led to considerable corporate strength over the past years.
We are continually reviewing and improving our efforts to lessen our impact on the environment and nurture a workplace of diversity and inclusion. We as a organization are striving hard to conduct our business responsibly and with high ethical standards in Manufacturing, Sales, Marketing and Research.
As a responsible member of today’s rapidly changing global community, we are making sincere efforts to adapt to the evolving needs of the society and also contribute to the overall health and wellness of the world.
Human Resource Department
Mr. Prasad Kulkarni (H.R. Manager)
+91 99001 80924
skybiotechhr@gmail.com
Current Openings
5 to 10 years of experience approval of any sections – Tablets / Capsule / Powder
5 To 10 years experience in process and quality documentation as per WHO-GMP guidelines. Should be able to face regulatory audits independently.
Candidate must have hands on experience on hosting Regulatory Audits for Africa & PIC/S . Must have experience in RA for Semi / non-regulated & emerging markets. Regularly Monitor changes in regulations
POST: 1
The Candidate will be responsible for handling manufacturing of Tablets, Capsules and Dry Syrup Formulation for Regulated Markets and un Regulated Markets like countries in African Continent CIS Markets, Middle East Markets and South Asian Markets. He will look after entire production process and ensure compliance to cGMP norms and will closely work with all the other Departments and functions with focus to enhance return on present facility & resources besides ensuring quality confirming to international standards. He will Handle Man power and ensure total / effective utilization of man power. The incumbent will be responsible for Production, Planning & related functions.
Responsible for direction, strategic planning & execution of Plant operations
POST: 1
1 – Sampling and Testing Raw Material and Packing Material
2 – Wet Lab Analysis (Raw, Semi finish, Finish product)
3 – Working Standard Preparation.
4 – Handling Instrument FTIR, UV-Visible Spectro Photometer, Gas Chromatography, Auto Titrator,
HPLC
5 – Water Analysis.
6 – Standardization and preparation of volumetric solution
6 – Chemical reagent and indicator Preparation
7 – Handling and arrangement of Lab Chemical, Reagent and Glass ware.
8 – Knowledge of ERP System, LIMS / SAP and others.
9 – Qualification of all QC Instruments
10 – Knowledge of GLP
11 – Preparation of SOP , STP and Protocol.
12 – Knowledge of (Analytical Method Validation , Water validation , Process Validation , Cleaning
Validation).
13 – Handling of stability study – protocol preparation, Stability Sample analysis as per schedule at
different condition.
14 – Procurement and Handling of Reference Std
15 – Knowledge of handling OOS, OOT, Change Control and deviation.
16 – Knowledge of Regulatory Guideline like ICH, PIC/S and 21 CFR.
17 – Exposure to face audit like WHO, and other regulatory Authorities from African Continent, CIS
Countries, Middle East Countries and South Asian Countries.
POST: 4
Managing Functions of Quality Control Systems, cGMP compliance, Validations, Analysis of Pharma Raw Materials & Finished Products, Control over day-to-day activities of QC Dept with Chemical Laboratory, Instrumentation & Microbiology. Good exposure of HPLC, GC handling. Knowledge of GLP.
B.Pharm/ M.Pharm/ M.Sc. with experience of 2-3 years in Pharma. Well conversant in Drugs Acts & Rules and Pharmacopia like IP, BP and USP, WHO-GMP etc. Experience of all aspects of QC, Capacity
to Head Q.C Team of 10.
POST: 1
Responsible for providing quick & on-time results to the IPQC department. Responsible for all documentation work such as RM, IPQC,FP, stability samples, validation etc.
Execution & Review of Instrument qualification ( IQ, OQ & PQ)
POST: 1
Should manage and schedule the packing plan for different product in various sections, Allot Manpower and get the packing done efficiently. Report all the activities to senior Management. Prepare BMR, BPR. Achieve the targets of Packaging Section. Should understand the different aspects of CGMP and should
have faced GMP audits
POST: 1
Current Openings
QA Activities, Documentation, SOP’s, IPQC – Activities – Process Control, Co – Ordination with other
Dept. like Production, Store, Quality Control, Engineering and Establish Quality Systems.
POST : 3
3 To 8 Years of experience in documentation, SOP’s, IPQC activities, Process control etc. Inter department co-ordination & establishing quality system.
Capsule filling, Bottle packing, Blister packing, Alu-Alu pack, Strip pack machines, Tablets Granulations compressions, ORS packing machine.
Qualification: ITI 12th / D engg with 2 To 10 years of relevant experience in Pharma Formulation
Validations and Qualifications, Preparation and implementation of the VMP & CMP. Process validations,
Cleaning validation, Facility validation. Equipment / Instrument qualifications (URS/DQ/IQ/OQ/PQ).
Deviation/ Incidences handling, Internal quality audits & GMP audit system, Annual Product Review,
Vendor audits and qualifications, Documentation, Effective implementation of the Document control
system, Preparation of Standard operating procedures (SOP), GMP & GLP records, Preparation &
approval of Master Formula Records, Batch manufacturing records, Quality Control & Stability Study,
Fully conversant with the latest GLP requirements, Handled all sophisticated instruments like HPLC,
GC, FTIR etc independently, ANDA and EU submissions, Handling of regulatory deficiencies/ queries
Work, Preparation of Drug Master Files & dossiers for export markets.
POST:1
Candidate will be responsible for handling Regulatory Affairs for Pharma Formulations for South East Asian, CIS Countries and African markets. You will be required to compile the Registration documents as per regulatory norms of specific countries, handle queries & do dossier compilations.
POST: 2
Candidate must have hands on experience on hosting Regulatory Audits for Africa & PIC/S .
Must have experience in RA for Semi / non-regulated & emerging markets.
Regularly Monitor changes in regulations
POST: 1
Co-ordinate the activities related to stability study with production & QC. To prepare and review stability protocols and reports. Compilation of stability study reports and co-ordinate with regulatory department to provide required data. Prepare Monthly stability schedule and maintain track of stability studies. Ensure charging and withdrawal of stability samples as per schedule. To review stability reports with respect to specification and MOA. Identify OOS /OOT in stability report through review. Ensure compliance to GMP during day by day activities for stability section. Prepare and review of stability chambers qualification and daily status. Should be aware about regulatory requirement with respect to stability study.
POST: 1
Should be able to negotiate the rate. Should be able to make Purchase Order, and release advances and payments as per the commitments, Should be honestly. Should understand the specifications of Packing Material. And expedite and manage the supply chain to deliver the PM in time for production.
To develop a procurement strategy and support achievement of business objectives for Packaging Material. To drive sourcing process excellence including high efficiency in transactions, reduced procurement lead times, strategic sourcing and efficient material management. Execute strategic sourcing initiatives in line with organizations objective. Responsible for vendor management – managing relationships, resolving issues and developing new vendors.
POST: 1
Validations & Qualifications, Preparation & implementation of the VMP & CMP. Process validations, Cleaning validation, Facility validation. Equipment / Instrument qualifications (URS/DQ/IQ/OQ/PQ). Deviation/ Incidences handling, Internal quality audits & GMP audit system, Annual Product Review, Vendor audits and qualifications, Documentation, Effective implementation of the Document control system, Preparation of Standard operating procedures (SOP), GMP & GLP records, Preparation & approval of Master Formula Records, Batch manufacturing records, Quality Control & Stability Study, Fully conversant with the latest GLP requirements, Handled all sophisticated instruments like HPLC, GC, FTIR etc independently, ANDA and EU submissions, Handling of regulatory deficiencies/ queries Work, Preparation of Drug Master Files & dossiers for export markets.
POST: 1
QA Activities, Documentation, SOP’s, IPQC – Activities – Process Control, Co – Ordination with other Dept. like Production, Store, Quality Control, Engineering and Establish Quality Systems.
POST: 2