Hiring QC Senior Manager at Syngene International Ltd

Syngene International Ltd is an integrated research, development and manufacturing services company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical sectors. Syngene’s 4500+ scientists offer both skills and the capacity to deliver great science, robust data management and IP security and quality manufacturing, at speed, to improve time-to-market and lower the cost of innovation. With a combination of dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb, and Herbalife, as well as 1.9 Mn sq ft of specialist discovery, development and manufacturing facilities, Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA.

Post : QC Senior Manager (52701)

Department : Quality Control - Biopharmaceuticals

Job Description :
• Senior Manager – QC Operations is responsible for testing and release activities of Biologics at Syngene International Limited.
• Senior Manager – QC Operations will report to the Head of Quality Control Biologics and act as a delegate to the Head of Quality Control Biologics in the latter’s absence.
• Senior Manager leads the operations in QC Biologics (Drug substance and Drug Product) related to the following areas;
• In-process testing and release
• Final Product testing and release
• Stability testing
• Method Validation and Transfers
• Senior Manager shall be responsible for GMP and GLP compliance and other regulatory requirements in QC lab.
• Senior Manager – QC Operations shall collaborate with other stakeholder like Program Management, Strategic Sourcing, Manufacturing, Engineering and Maintenance, EHSS, Quality Assurance, Analytical Development to ensure successful project deliverables and milestone accomplishments.
• A team of approximately 40 members report to Senior Manager – QC Operations
• Senior Manager – QC Operations is responsible to ensure all KPI’s are met related to project timelines for QC testing portion. He/She shall ensure work plans are periodically updated to address any changes in scope, priorities or timing.
• Participate in functional and cross functional teams and ensure testing of Biologics products as per cGMP compliance.
• He/she shall always adhere to ALCOA principles on data integrity as applicable for work area for self and team
• Establish robust governance process for effective review of the function and escalate key concerns to the senior leadership in formal and timely manner.
• Responsible to investigate any deviation, Incident, OOS, OOT, client complaints related to QC testing in Biologics and assess the impact on product quality and propose and implement remedial actions to prevent such occurrences.
• Responsible to participate in investigation and closure of client and regulatory audit observations in QC Biologics.
• Provide QC representation for regulatory filing wherever required (e. g. Prior Approval Submissions, renewals/updates/supplements etc.), Ensure timely update of Annual Product Review (APR/PQR) for Biologics QC batch release sections.
• Manage, coach and develop QC team and contribute to their growth. give directions and monitor team activities to deliver excellence.
• Proactively monitor various Quality control trends, complaints, failures, deviations and changes to identify opportunities for system, process and product improvements within QC Biologics.
• Shall identify continual improvement opportunities in various work areas of QC Biologics and ensure implementation of the same.
• Shall participate in assessing the continues state of regulatory compliance in SOP’s and ensure timely updates or revisions to procedure.
• Preparation of capital and revenue budgets, manpower projection requirement on a yearly basis.
• Recruit, induct and integrate associates into Syngene system.
• Responsible to meet project timelines related QC Biologics operations. Ensure work plans are periodically updated to address any changes in scope, priorities or timing.
• Establish robust governance process for effective review of the function and escalate key concerns to the senior leadership in formal and timely manner.
• Any other responsibilities that may be assigned by Head – Quality Control Biologics and/or Senior Management.

Candidate Profile :
• M.Sc Microbiology / M.Pharma
• Experience in Chromatography, Bioanalytical and Bioassay methods for mono-clonal antibodies an other biologic molecules.
• Ability to work successfully in a dynamic, ambiguous environment.
• Ability to meet tight deadlines and prioritize workloads.
• Ability to develop new ideas and creative solutions.
• Should be able to motivate team and make the team productive.
• Should be a focused employee.
Minimum 15 years and above.

Behavioral Skills :
Strong commitment towards work, and a high level of dedication, enthusiasm, motivation, and persuasive ability in a team. Good speaking-listening-writing skills, attention to details, proactive self-starter.

Additional Information
Experience : 15 years
Qualification : M.Pharm, M.Sc
Location : Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 30th December, 2022