Sr. Manager Manufacturing Operations

JOB DESCRIPTION

Job Title: Sr. Manager Manufacturing Operations

Job Location: Bangalore

Department: FD Manufacturing

About Syngene: Syngene () 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 companys 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 integrityhealth 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

Role Accountabilities

• Responsible for the transfer of technology from TS to RS and vice versa.
• Preparation review and approval of Technology Transfer Protocol and report PRA PSI QRA etc.
• Responsible for preparation review and approval of documents related to New product introduction w.r.t Formulation production.
• Responsible for planning organizing and ensuring that manufacturing and other functions are run cost-effectively and to ensure facility operation within the laid down annual revenue budgets.
• Documentation Management for preparation and/or review of the SOPs EOPs IOPs. BMR/BPR/MFR/MPR etc documentation activity by both manually and in electronic document management system (EDMS) as author or reviewer.
• Review of Executed documents but not limited to Batch records protocols etc.
• To review facility capacity and equipment feasibility with respect to rolling plan and new product requirements and to initiate proposals for procurement of new equipment facility up-gradation and expansion.
• To be updated with current regulations to operate the plant and upgrade the required system and equipment as and when required.
• Document management for Preparation and Review of URS DQ IQ OQ and PQ of equipments/ instruments etc. both manually and in Electronic Document Management System (EDMS) or Validator as an author or reviewer.
• Responsible for entire plant area validations and qualifications to meet projected timelines.
• Support for FAT evaluation and review of equipment risk assessment assist in protocol review for decommissioning of existing equipment and commissioning from at new and existing facility.
• Coordination with the cross-functional department for the completion of production targets and support for achieving production numbers weekly monthly and annually.
• Responsible for facility planning to achieve weekly monthly targets capacity utilization monitoring and up keeping for smooth functioning of production activities clinical batches manufacturing/commercial batches manufacturing.
• Responsible for ensuring an adequate number of qualified & trained personnel are available for various functions.
• Responsible for ensuring the implementation of best practices for Human relations management through proper recruitment training practices & retention of good-performing employees of the department.
• To review facility capacity and equipment feasibility with respect to rolling plan and new product requirements and to initiate proposals for procurement of new equipment facility upgradation and expansion. To be updated with current regulations to operate the plant and upgrade the required system and equipment as and when required.
• Responsible for approval of purchase order for new instruments /equipments accessories and consumables for day-to-day functioning of formulation production.
• Co-ordination with other functions like project management HR Formulation & Development Regulatory QA & QC with respect to various plant-related activities for completion of production targets and support for achieving of production numbers for weekly monthly and annually. And ensuring monthly production targets are met as per requirement by complying to predetermined quality standards as applicable.
• Management of QMS documentation as a part of review process of change controls deviations investigations CAPA OOS OOT Customer compliant Audit management APQR validation protocols study protocols etc. as per need both manually and in electronic Quality management system (EQMS).
• Complete online and offline training on time.
• Responsible for client visits department audit preparation and monitoring.
• Responsible for implementation of cGMP requirements to meet compliance w.r.t. USFDA EU MHRA standards.

Syngene Values

All employees will consistently demonstrate alignment with our core values

• Excellence
• Integrity
• Professionalism

Experience

• Relevant handson experience in Oral solid dosage form and Injectable.

Skills and Capabilities

• To participate in periodic management review meetings self-inspections and internal quality audit.
• To ensure and implement procedures to target Zero Incidents.
• Supporting for Preparation and review of documents like but not limited to BMR/BPR/Protocol/Report etc related to S18 Injectable fill-finish facility.
• Strong leadership and handson expertise in sterile injectable drug product manufacturing including aseptic processing compounding filtration filling inspection packaging and facility operations in compliance with cGMP.
• Indepth knowledge of QMS GDP data integrity and regulatory requirements with proven capability to review approve and drive SOPs protocols QRM study reports deviations change controls and CAPAs.
• Extensive experience in equipment and facility lifecycle management encompassing installation commissioning FAT/SAT IQ/OQ/PQ periodic requalification and routine validation activities.
• Strong crossfunctional coordination skills enabling effective collaboration with Engineering Validation Quality Assurance and other stakeholders for calibration preventive maintenance qualification and issue resolution.
• Demonstrated capability in regulatory and customer audit management including inspection readiness audit trail oversight alarm trending review responses to observations and CAPA implementation.
• Proven people management and development skills including training strategy mentoring performance oversight and fostering a strong GMP and safety culture within the manufacturing team.
• Ability to drive continuous improvement risk management and operational excellence aligned with current regulatory expectations and business objectives.

Education

• Masters degree/ bachelors degree in pharmacy masters degree in Pharmaceutical Sciences.

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 addition Syngene will provide reasonable accommodations for qualified individuals with disabilities.