Greetings from Sun Pharma..!!!
We are hiring following positions
Job Title : Sr. Manager QC
Qualification: M.Sc/ B.Pharm/ M.Pharm
Experience: 13- 15 years
Location : Guwahati
- To monitor and ensure that In-process/ Finished products samples are tested and released in time to meet market/customers requirements.
- Accountable for Quality of intermediates and finished products, which are released as per the specification.
- Responsible for productivity improvement by optimization of instruments utilization, troubleshooting of analytical methods and resource planning for responsible sections.
- Responsible to participate and implement laboratory continuous improvement/ Lean lab programs
- Co-ordination for technology transfer products during new product manufacturing/ launches for analytical method transfers and timely releases.
- To review the laboratory investigations and to ensure the timely decision for further actions w.r.t. extended investigation, timely escalation of OOS/OOT findings to QA and Plant Management.
- Review & Approve protocol/report for Analytical method validation, Analytical method transfer, Process validation, Cleaning validation, Qualification, Continued process verification and additional sampling/activity or any study required by Validation master plan.
- Ensure compliance to cGMP/GDP/ cGLP at all operational activities and participate in internal/ external audits
- To ensure the harmonization and consistent implementation of Quality Systems and Good Laboratory Procedures at site, in alignment with Global Quality Policies and Standards.
- To ensure the implementation of CAPA to address the internal/external audit findings in QC labs within stipulated time frame.
- To participate in risk assessment and Appropriate action in co-ordination with QA department
- To review & monitor training calendar, on-job training completion, reconciliation and compliance.
- To review and approve the activities under contract lab testing (External lab).
- To Co-ordinate of Instrument maintenance, Calibration, Qualification and Troubleshooting.
- To Coordinate and ensure the procurement of Standards, Impurities, Lab consumables are of good standards and are managed with full records of receipt, storage, issuance and disposal
Job Title: Manager/ Sr. Manager – Regulatory Affairs (Biosimilar)
Experience: 13 – 15 years
Qualification : B.S. M.S. (preferably with PhD) in a biological science, bioengineering, or a related field (advanced degree preferred). Fields of study include Biology, Biotechnology, Life sciences, Microbiology, Virology, Molecular Biology, Chemical Engineering, or Biochemistry
- Serve as a Regulatory CMC Product Lead and provide CMC Regulatory leadership within Regulatory and on cross-functional teams for the assigned biological products in the pre-approval space.
- The CMC Product Lead is accountable for the delivery of all regulatory milestones for higher complexity products in which responsible including assessment of the probability of regulatory success together with risk mitigation measures.
- Lead the development, communication, and review of the CMC Regulatory Strategy Document for projects of increasing complexity.
- Provide regulatory leadership as needed in product in-license/due diligence review, product divestment and product withdrawal.
- Manage execution of CMC documentation including IND/CTA, original BLA/MAA, agency background packages and responses to health authority questions per established business processes and systems.
- Support new technology development within our Company.
- Demonstrate an understanding of regulatory affairs and applies this understanding to the benefit of the company to ensure the approval and continued market supply of our Biologics products worldwide.Conduct all activities with an unwavering focus on compliance
- Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data.
- Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner. Strong listening skills.
- Demonstrated sound understanding of related fields (e.g., manufacturing, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving
- At least fifteen (15) years of relevant experience (10 years with an advanced degree), including biological CMC development; manufacturing, testing, or licensure in regulated markets for biological products; biosimilars, or related fields.
- The candidate must be proficient in English; additional language skills are a plus.
- Experience in Biologics preferred.