Technician – Production (Injectable)
Qualification : ITI / Diploma
Experience : 2-8 Yrs
Desired Exposure : Parenteral manufacturing / Sterile manufacturing Suspension / emulsion / BFS as well as SKID operation. Experience of handling equipment’s like Groningcr vial filling, Fedegari Autoclave, NKP vial Filling machine, lyophilizcr, Spray dryer.
Officer / Executive – Production (Injectable)
Qualification : B.Pharm / M.Pharm
Experience : 2-8 Yrs
Desired Exposure : Parenteral manufacturing / Sterile manufacturing Suspension / emulsion / BFS as well as SKID operation. Should have experience in Aseptic process, complex manufacturing, Exposure to CIP/ SIP SKID.
Officer / Executive – Eng. (Plant Maintenance)
Qualification : B.E. – Mech./Elect./ Inst.
Experience : 2-8 Yrs
Desired Exposure : Maintenance of Sterile Manufacturing Plant, maintenance of Autoclave, Filling machine – Vial, Ampoule, Ophthalmic, Lyophilizer, Freeze dryer machine
Officer/ Executive – Micro.
Qualification : M. Sc – Microbiology
Experience : 2-8 Yrs
Desired Exposure : EM activity, Water / Bio burden Testing, BET Testing, Endotoxin Testing, Sterility Testing, and Microbiological Media Preparation.
Officer / Executive – Eng. (Utility)
Qualification : B.E. – Mech. / Elect.
Experience : 2-8 Yrs
Desired Exposure : Parenteral Manufacturing Plant and knowledge of operation and maintenance of HVAC, QMS Documentation, operation and maintenance of nitrogen Plant.
Baddi
Date : 23rd April 23 (Sunday)
Time : 9:30 am to 5:00 pm
Venue : Hotel Legend Sarovar Portico
Malpur Rd, Malpur Upperla, Baddi
Haridwar
Date : 22nd April 23 (Saturday)
Time : 8:30 am to 4:00 pm
Venue : Hotel Yashail (Old Name – Radisson Blu)
Plot No. C-l, Sector 12,BHEL Township, Haridwar
Candidate must bring copy of PAN & Aadhar Card, Education Certificates, Last 3 months salary slip & CTC structure.
Pharma Jobs in Regulatory Respiratory at Cipla – M.Pharm, B.Pharm Apply
Post : Team Member – Regulatory Respiratory
Job Description
Job Purpose
Prepare, review, ,modify, collate, submit documents for product registrations and maintain life cycle of respiratory products, update regulatory database, support launches and ongoing commercials to meet the objectives of regulatory affairs sub-function
Accountabilities
I. Check region-wise regulatory requirements, perform gap analysis for registered dossiers, compile/recommend regulatory strategy for product submission to check leveragability, and to support development activities
II. Compile respiratory product dossiers by collating and reviewing relevant registration information, submit dossiers as applicable, compile deficiency responses to facilitate timely approvals of respiratory products globally
III. Support on-time launches and ongoing commercials of respiratory products and devices identified by the business plan through cross functional co-ordination and review of documents to ensure launch within timeline
IV. Update and provide the regulatory status of respiratory products for maintenance of the global registration database
V. Manage post-approval life cycle management by contributing to the closure of change controls, by compiling and submitting regulatory packages, relevant to life cycle management to
VI. Support portfolio initiatives eg. identifying leverage products by evaluation of data, compliance with respect to site transfer initiatives to
VII. Participating in Control Tower, SAP, CIPDOX, GOOSE, meetings on behalf of respiratory team
Candidate Profile
Bachelor’s / Master’s degree in Pharmacy
Relevant Work Experience
6 years experience in regulatory filing (compilation, submission and approval) with knowledge of drug product development and respiratory products (for US/EU/International markets)
Communication Skills (clarity of thought, comprehension)
Likely potential for growth
Job / Product / Technical Knowledge / Pharma domain knowledge
Presentation & Interpersonal skills (If applicable)
Managerial or People Management skills
Safety awareness (If applicable)
Relevance of Previous Experience
Comprehension, Analytical & Problem solving abilities
Productivity & Result Orientation (If applicable)
Attitude
Qualification fitment
Sales drive (If applicable)
Personality traits (Individualistic / Team player, Out spoken, Maturity level etc.)
Additional Information
Experience : 6 years
Qualification : Bachelor’s / Master’s degree in Pharmacy
Location : Vikhroli
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Regulatory Respiratory
End Date : 30th April, 2023