Title:  Lead Manufacturing Operations -OSD

JOB DESCRIPTION

Job Title: Lead Manufacturing Operations -OSD         

Job Location: Biocon Park, Bengaluru

Department: Drug Product Manufacturing

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 always.
• Ensuring safety of self, teams, and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements always 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 always
• 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: The primary purpose of this role is to ensure the highest standards of manufacturing compliance and quality for Oral Solids (tablets, pellets, capsules, liquid-filled capsules at Syngene International Limited. This encompasses the management of regulatory audits and overseeing Corrective and Preventive Actions (CAPA) to drive continuous improvement. This role is essential for ensuring operational excellence, regulatory adherence, and the delivery of high-quality pharmaceutical products, ultimately contributing to Syngene International Limited’s commitment to patient safety and industry leadership.

Role Accountabilities:

• Responsible for ensuring that all the Oral solids manufacturing & packaging is all time audit ready and in compliance with cGMP and regulatory expectations from USFDA, EU, MHRA, Health Canada.
• Management of QMS documentation as a part of review process of change controls, deviations, investigations, CAPA, OOS, OOT, Customer compliant, APQR, validation protocols, study protocols etc.
• Actively review the implementation of Quality Management System (QMS) within the function to ensure that processing activities are being conducted in accordance with QMS requirements as well as current regulatory and quality standards.
• To drive high impact projects on cost saving, process improvement at Development and manufacturing,
• Support for working on annual Capex & Open requirements & all the operations are run-in cost-effective manner.
• To review facility capacity and equipment feasibility with respect to rolling plan and new product requirement and to initiate proposals for procurement of new equipment, facility upgradation and expansion.
• Document management for review of URS, DQ, IQ, OQ and, PQ of equipment’s/ instruments etc. as a reviewer.
• Responsible for improving the efficiency and effectiveness of business operations by identifying and implementing process.
• Co-ordination with cross functional teams to ensure facility is in state of compliance and to meet production targets.
• Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company’s integrity & quality standards.
• Govern and Review safety metrics from time-to-time following environment, health, and safety (EHS) requirements always in the workplace.
• Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all team members.

Leadership Capabilities:

• Proficient in managing multiple projects simultaneously.
• Strong problem-solving skills to address compliance issues swiftly and effectively.
• Ability to lead and motivate cross-functional teams.
• Foster a collaborative environment that encourages open communication and accountability.
• Drives Performance against outcomes.

Syngene Values

All employees will consistently demonstrate alignment with our core values.

•  Excellence
•  Integrity
•  Professionalism

Accountabilities as a Syngene Leader (only for Leadership Hires)

• Champion effective Environment, Occupational Health, Safety and Sustainability (EHSS) practices for the company and oversee compliance with those practices within Biologics business. Play an active leadership role in monitoring and verifying safety performance through Gemba walks and other safety-led activities.
• Foster a corporate culture that promotes an environment, occupational health, safety, and sustainability (EHSS) mindset as well as the highest standards of quality, integrity, and compliance.

• Put people at the heart of our success by providing clear, active leadership defined by the Syngene leadership framework setting high standards of people management, career planning and talent retention as a priority.

Specific requirements for this role

Experience: Having experience of more than 18 years in manufacturing operations in oral solids. Having experience in injectable will be an added advantage in global pharmaceutical companies.

Skills and Capabilities:

• Regulatory Audits from FDA, EMEA, Health Canada.
• To participate in periodic management review meetings, self-inspections, and internal quality audit.
• Expertise in conducting thorough investigations, CAPA management, OOS.
• Strong analytical capabilities to assess compliance data and identify trends.
• Proficient in Oral Solids product manufacturing and process troubleshooting.
• To be part of QRM assessment, BMR, BPR, artwork review.
• Expertise in Injectable manufacturing will be an added advantage.

Education: Postgraduate in pharmacy

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 regarding 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.