Team Member – API Tech Transfer
Job Purpose
Execute and implement the API technology transfer activities in plant to ensure robustness of process in line with proper safety requirements
Accountabilities
I. Execute tech transfer activities at CMO and scale up batches at plant, for new molecules, to ensure safe transfer of process
II. Monitor the pre-validation and validation cycle batches at plant and conduct knowledge sharing training sessions for shop floor staff to ensure accurate identification of critical process parameters
III. Create documentation in compliance with SOPs for API technology transfer
IV. Compile the data for plant hardware and provide inputs for equipment mapping
- Education Qualification
B. E. Chemical/ B.Sc. Organic chemistry
- Relevant Work Experience
2 to 3 years of experience in manufacturing or technology transfe
Job Purpose
Be responsible for maintenance of the process safety (major hazards) management system including HAZOP process documentation, trainings, management of change, quality of process safety incident investigation, CAPA actions and ensure that the learnings are imparted site wide.
Job Purpose
The incumbent is a team member of Engineering Maintenance & Reliability Team and carries overall responsibility to:
1. Execute the maintenance activities in the plant & ensure the minimum breakdown with maximum efficiency by following safety & GMP Standards
2. Support Senior Engineer in carrying out Functional EM&R Planning, Detailed Scheduling and Execution of CMP to- ensure continuity of availability of plant & equipment at optimal cost; achieve standard capacity; ensure overall plant & equipment integrity & reliability – in compliance with Cipla Policies, Standards & Procedures; Reporting of EM&R MIS, Incidents & Deviations @ SOP;
Functional Engineer is responsible for executing maintenance tasks as assigned by Senior Engineer for his function in the Manufacturing, Packing and utility areas.
Where outsourced, 3rd Party Functional Engineer is accountable for the Service Floor / Technical Floor maintenance execution
Education Qualification
BE / B Tech (Electrical)
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
2 years of experience in quality assurance department
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
Education Qualification
M.Sc. / B. Pharma
Relevant Work Experience
1-3 years of experience in QC department of a pharmaceutical organization
Submit product documents to regulatory authorities in accordance with country specific regulatory requirements to ensure approvals and market launch in stipulated time and handle post-approval changes, maintenance, and updation of documents during the products life-cycle
- Education Qualification
B.Pharmacy, M. Pharm, Bsc or MSc
- Relevant Work Experience
Minimum 5 yearsâ experience in regulatory activity in pharma industry preferably worked for same region/authority
Monitor and execute the packing activities in a shift by maintaining cGMP and safety norms to achieve production targets
Education Qualification
B. Pharm. / B. Sc. (Chemistry)
Relevant Work Experience
2 years of experience in packing with knowledge of handling of QMS activity, qualification and other related documents
- Bachelor’s degree (BS or BA), physical sciences preferred.
- Masters or (MS) or Doctorate (PhD)
- Proficiently speak English as a first or second language
- Proficiently communicate and understand (read and write) scientific work in English.
- Have excellent organization, learning and teaching skills required to work in teams.
- Ability to understand and analyze complex data sets.
- Working knowledge of Microsoft Office programs and other scientific based software
- Must have prior experience working in a QC lab.
- Pharmaceutical background/experience is strongly preferred.
- Understanding of lab equipment and QC testing techniques required.
