Senior Manager Quality Control-Biologics

Job Description

• Responsible for Quality Control operations (Product Support Stability studies & Raw material and Packing material), services and ensure compliance to Good Laboratory Practices and other regulatory requirements.
• Coordinating with ADB, QA and other departments for smooth transfer of new analytical methods.
• Ensure to release of Finished product, Intermediate product, Stability samples, Raw materials with in assigned TAT.
• Ensure the qualification, validation, performance and transfer of analytical methods within the Biologics Department.
• Co-ordinate with instrument vendors for maintenance wherever applicable.
• Interaction with client and project team for smooth functioning of project related activities.
• Shall be responsible to ensure all Quality Control test methods, test protocol, technical reports related to Biologics operations are in compliance with the current pharmacopeial / regulatory requirement.
• Collaborate with Biologic process development team to plan and execute testing to support Biologic drug substance/drug product development and manufacturing.
• Ensuring the laboratory incident / OOS / deviations/ OOT/ client complaints related to QC testing in Biologics are investigated, derived root cause and CAPA implemented in timely manner.
• Coordinate with regulatory for preparation of CTD, DMF and regulatory queries.
• Ensure that all the instruments are calibrated as per the laid down procedures and with defined frequency.
• Ensure that all documentation (SOP, IOP EOP, STP) are revised periodically, maintained and is updated online.
• Ensuring all members of Quality Control Biologics undergoes the required training and their knowledge and skills are updated to perform the duty efficiently.
• 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.
• Participate in functional and cross functional teams and ensure testing of Biologics products as per cGMP compliance.
• Always Adhere to ALCOA principles on data integrity as applicable for work area for self and team.
• Establish functional working team for self-assessment of compliance to SOP s and Data integrity.
• Ensure documented action plan and timely closure of audit observations, escalate as appropriate.
• 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 and closure of client and regulatory audit observations in QC Biologics. Ensure all personnel follow lab safety practices as necessary and shall be responsible for mitigation of technical troubleshooting in QC Biologics.
• Provide QC Biologics 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 Biologics batch release sections.
• Manage, coach and develop QC Biologics 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.
• To follow the safety norms and constantly adhere to Syngene safety policies.
• To bring out any safety concerns and to participate in safety related activities.

Educational Qualification: Masters in scienceExperience: >15 yearsTechnical/functional Skills:

• Overall responsible for Quality Control operations (Product Support Stability studies & Raw material and Packing material), services and ensure compliance to Good Laboratory Practices and other regulatory requirements.
• Planning and managing resources for smooth operations at QCB lab.
• Ensure to release of Finished product, Intermediate product, Stability samples, Raw materials with in assigned TAT.
• Interaction with client and project team for smooth functioning of project related activities.
• Manage, coach and develop QC Biologics team and contribute to their growth. Give directions and monitor team activities to deliver excellence.

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.
• 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 able to motivate team and make the team productive.
• Should be a focused employee.

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Keyskills :
gmpmanagementsopcommitment towards workenvironmental impact assessmentequal employment opportunitycontinuous improvement facilitationqualityleadership