Team Lead - QC Late Phase Stability

JOB DESCRIPTION

Job Title: Team Lead - QC Late Phase Stability.

Job Location: Syngene International Limited, Bengaluru

About Syngene:  Syngene (www.syngeneintl.com) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply.

At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit

Mandatory expectation for all roles as per Syngene safety guidelines

• Overall adherence to safe practices and procedures of oneself and the teams aligned
• Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company’s integrity & quality standards
• Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times.
• Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace.
• Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self.
• Compliance to Syngene’ s quality standards at all times
• Hold self and their teams accountable for the achievement of safety goals
• Govern and Review safety metrics from time to time

Core Purpose of the Role:

This is an exciting opportunity to play a role in the Quality control late phase stability department of Syngene. The role will provide several responsibilities of Stability Operations, stability sample management, Chamber preventive maintenance and calibration, data review, facing regulatory and client audits. Lab safety requirements, Compliance as per Syngene policy and EHSS requirement. It provides an opportunity to handle overall Stability Operations Management.

Role Accountabilities

• Monitoring of stability chambers with ICDAS software. Acknowledge all alarms generated by the stability chambers in ICDAS software.
• To ensure cleanliness of the stability chambers and update relevant records
• Ensure yearly chamber mapping is done as per schedule.
• Carry out Alarm trending activity in line with the SOP.
• Preparation of Stability Protocols.
• Labelling of stability samples and initiation of stability studies in line with the approved protocol.  Updation of Stability inception and pull register.
• Prepare stability monthly schedule and pull samples within the specified time window as per the SOP. Updation of relevant records.
• Receipt of Samples for both Integrated and standalone Stability Initiation. Co-ordination with relevant departments with regard to the same activity
• To Initiate Change control, Incidents, CAPA and Deviations (QMS documents) as applicable.
• To carry out destruction of reserve samples post completion of the study in a compliant manner and update relevant records.
• Preparation of SOP’s/ IOP’s for Stability Operations.
• Preparation of yearly calibration and preventive maintenance planners, preparation of monthly calibration schedule.
• Preparation of Static data where applicable. Assist in implementation of minor changes to LIMS stability module or related validation activities.
• To co-ordinate with E&M and Vendor for Qualification of all Stability Chambers, calibration, Preventive Maintenance and review of all related documents.
• Actively participate in Client, Internal and Regulatory Audits.
• Strictly adherence to c-GMP, GDP and data integrity procedures.
• Ensure and comply with EHS policies laid down by the organization.
• Responsible to complete assigned training on time.
• Responsible for timely delivery of stability projects.
• Ensure optimal utilization of work hours and prioritization of the activities to meet departmental commitments.
• Escalation of issues/ nonconformity with applicable procedures/ policies.
• Ensure 100% adherence to safety requirements implemented in Syngene.
• Participate and implement operational excellence requirements.
• Take necessary action with regard to QMS where required.

Syngene Values

All employees will consistently demonstrate alignment with our core values

•  Excellence
•  Integrity
•  Professionalism

Specific requirements for this role

1. Experience
2. Demonstrated Capability
3. Education

Experience: 09 to 12 Years

Skills and Capabilities

LIMS Labware, Regulatory and Client audit facing capabilities, Good communication skills, partnering with others, capable of thinking scientifically to address complex problems and develop solutions.

Work as a team and have a collaborative mindset.

Education: MSC/ B. Pharm/M. Pharm.

Equal Opportunity Employer

It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.