Cipla Ltd Hiring 2023.Cipla Ltd Notification full details below.Interested and eligible candidates can Apply Now.Cipla, as an organisation has been built brick-by-brick on the foundation of care. Caring For Life has always been and continues to remain, our guiding purpose. Driven by the same purpose, we have extended our presence to 80+ countries providing over 1,500 products across various therapeutic categories in 50+ dosage forms.
Vacancy details:
- Post Name: Junior Team Member – Microbiology/Junior Team Member – QC/Senior Operator – Production/Team Member – QA/Junior Operator – Production/Drug Safety Manager
- Qualification: University graduate of a science degree or Masters in a medically related discipline./B.Sc (Microbiology)/M.Sc. / B. Pharma/Diploma in Pharmacy / Mechanical Engineering
- Experienced: 2-5 Years
Job Description: Greeting from Cipla Ltd !!!!!
Important Details :
- Post of date:21/08/2023
- Location: Maharashtra – Goa
- Selection Process: The selection will be on the basis of Interview.
- Mode of Interview: Face To Face Interview
- Interview Rounds of Interview: HR
Junior Operator – Production
Job Purpose
Execute the production operations in line with safety and GMP requirements to meet the manufacturing targets in shift
Accountabilities
I. Operate the equipment efficiently without error and deviation as per SOP to meet shift targets
II. Provide suggestions for optimization of processes to manufacture quality product
III. Execute and update online documentation to meet cGMP requirements
IV. Deliver training to workmen and adhere cGMP and safety guidelines in production process to ensure smooth operations
Education Qualification
Diploma in Pharmacy / Mechanical Engineering
Relevant Work Experience
5 years of experience in a manufacturing organisation preferably in pharmaceutical industry
Team Member – QA
Job Purpose
Review the compliance level of site for deficiency response, prepare master validation protocol and report as per company quality policy and applicable regulatory guidelines
Accountabilities
I. Collate, review and provide required work plans on received deficiencies to HO in order to respond to regulatory authorities in a timely manner
II. Review Master Validation protocol and report for timely execution of validation batches and timely submission of documents in order to response for deficiencies
III. Review annual product quality review report at units for completeness and data correctness to ensure compliance to cGMP requirements and audit readiness
IV. Review, upkeep and issue regulated market technical agreements at site for execution of batches as per customer requirement
V. Receive and distribute approval certificate, dossiers (TDP & RAP) and development report at unit for execution of new products smoothly
VI. Coordinate with auditors and site teams for regulatory and customer inspection/ audit at site to meet regulatory expectation and acquire GMP approvals
VII. Prepare final draft of compliance to audit observation and check whether it is in line with cGMP requirement to avoid regulatory action and continual improvements
VIII. Collect, compile and review raw data and finalise the same for timely submission of MHRA, UK interim update document to corporate as per agency requirement by tracking interim updates at a site level, for risk based inspection planning
IX. Drive continuous improvement initiatives in CQA to facilitate adherence to cGMP
X. Execute on time and errorless submissions by reviewing product license, all certificates for product registration and tender , staff approvals and other applications to adhere to legal requirements
XI. Support in CDSCO and state FDA inspection to be GMP compliant and getting product licence, FDA stall approvals by ensuring cross functional interaction
Education Qualification
B. Pharma/ M.Sc
Relevant Work Experience
3-4 years of experience in quality assurance department
Junior Team Member – QC
Job Purpose
Prepare, update and review the specifications, SOPs, policy and operating documents for analysis of materials in order to ensure alignment to predefined quality parameters and compliance to respective standards / pharmacopeia and cGMP requirements
Accountabilities
I. Prepare documents like SOPs, specifications and non-routine documentation and ensure timely availability across the site to provide support during the analysis
II. Review the latest pharmacopeial updates, supplements and amendments by evaluating the updates required in the available document to ensure the compliance with the current pharmacopoeia through consent with regulatory body
III. Review the assigned documents by referring the concern backup and pre-defined quality procedure to ensure its compliance against the quality requirements
IV. Issue documents to applicable units, by maintaining the record of the same in the issuance record (bound book) so the current version of the common document is available at the unit
V. Execute harmonization and simplification process of documents to reduce complexities in processes and ensure standardized procedures are followed
Drug Safety Manager
1. Drug Safety
Oversee and direct the drug safety activities and essential related tasks for the Company. This involves, but is not limited to oversight of the following areas:
- Establish and maintain a system which ensures that information about all suspected adverse reactions, which are reported to the company or organisation, including to medical representatives and clinical research associates, is collected and collated so that it is accessible at a single point.
- Collection, evaluation, processing and submission of Individual Case Safety Reports (ICSR’s).
- Preparation and submission of Periodic Safety Update Reports (PSUR’s), when necessary.
- Risk Management Plans (RMP’s).
- Negotiation, implementation and maintenance of Safety Data Exchange Agreements.
- Implementation and maintenance of Drug Safety System Database and Master Files and reconciliation of drug safety data.
- Conduct reconciliation with 3rd parties where required.
- Conduct literature searches as required by legislation.
- Respond to the SAHPRA and/or NADMC on safety queries related to Company products.
- Provide input to annual product quality reviews (APQR’s) where appropriate.
- Training of Company employees on the relevant drug safety procedures.
- Ensure drug safety compliance with relevant legislation appropriate for each jurisdiction in which Cipla Medpro markets products.
- Ensure that all drug safety processes and procedures are consistent and appropriate and that all Company staff are trained on the relevant procedures.
Education Qualification
University graduate of a science degree or Masters in a medically related discipline.
Relevant Work Experience and Skills
Minimum 5 years’ pharmacovigilance role covering all areas of the function.
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