Cipla Limited is an Indian multinational pharmaceutical company headquartered in Mumbai. Cipla primarily focuses on developing medication to treat respiratory disease, cardiovascular disease, arthritis, diabetes, depression, paediatric and various other medical conditions.
Team Member – QA
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
Competencies/Skills
Job Location
Goa
Junior Operator – Packing
Operate & maintain packing machines to achieve quality product & shift wise targeted output with maximum utilisation
Accountabilities
I. Prepare the machine for packing operation as per production plan by using proper resources to ensure smooth operations
II. Operate the packing machines by using minimum resources to get quality product
III. Execute and update online documentation to meet cGMP requirements and maintain data integrity Fill Machine logs. Document entries/SOP and process simplification to meet cGMP.
IV. Perform packing machine operations safely to avoid safety incidences by appropriately handling the machines and thereby maintaining high standard of safety
V. Deliver training to workmen and adhere cGMP and safety guidelines in production process to ensure smooth operations
Education Qualification
Diploma in Pharmacy / Engineering
Relevant Work Experience
2 years of experience in packing with knowledge of handling of QMS activity, qualification and other related documents
Competencies/Skills
Job Location
Rangpo
Team Member – LCM
Implement Life cycle management activities for Non-respi products (for US, EU, South Africa, ANZ, WHO, PEPFAR & 150+ countries ) to have Business continuity
Accountabilities
I. Assess change request across the globe allocated by GL to review, evaluate and categorize the change as per regulatory guidelines to meet launches, commercial needs and compliance
II. Prepare variation packages for modules 2 to 5 and deficiency response across the globe to support commercial launches, on-going commercial and regulatory compliance.
III. Prepare annual report (US) as per schedule to meet regulatory compliance for business continuity.
Prepare WHO requalification dossier to maintain product licence for business continuity.
IV. Compile re-registration dossier to maintain product licence for business continuity.
V. Maintain and update product database for easy retrieval and status tracking
Education Qualification
Minimum Graduate in Pharmacy or Life Sciences
Relevant Work Experience
5 years in the field of Regulatory Affairs/ Quality Assurance/ Quality control/ Manufacturing/ Analytical Development/ R&D
Competencies/Skills
Job Location
Vikhroli
Junior Team Member – Microbiology
Execute analysis of allocated samples and Produce reliable and reproducible results in order to ensure their compliance to the microbiological quality parameters and predefined specifications and standards
Accountabilities
I. Analyse and review samples based on work allocation to meet the service level agreement
II. Report errors, abnormal observations, non-compliances related to procedures, equipment and instruments, and deliver results promptly to facilitate timely action and avoid delay in releases
III. Document entries, raw data and findings concomitantly in relevant test data sheets so as to facilitate the lab QA to review the reports and avoid missed entries
IV. Evaluate & document Instrument / equipment break down and suggest mechanisms to avoid the same
Education Qualification
B.Sc (Microbiology)
Relevant Work Experience
2 years’ experience in Microbiology
Competencies/Skills
Job Location
Rangpo