Associate

Syngene International; Bengaluru; On-site; INR 300,000 - 420,000; Full time

Job summary

Syngene International Bengaluru is seeking a manufacturing operator to execute production tasks in compliance with cGMP, GDP and data integrity policies. You will monitor shifts, ensure facility readiness, and coordinate preparation of master documents such as SOPs and BMRs.

The role requires a B.Sc. in Organic Chemistry with 1–2 years in manufacturing operations; familiarity with EHS guidelines, ALCOA data integrity and batch documentation is essential.

Qualifications

• B.Sc. in Organic Chemistry with 1–2 years of manufacturing operations experience.
• Knowledge of cGMP, data integrity and safety guidelines.
• Willingness to work in shifts and handle batch documentation.

Responsibilities

• Carry out manufacturing operations in line with cGMP and data integrity policies.
• Ensure facility readiness and monitor shift activities.
• Prepare master documents (SOP, ECC, BMR, PDR) for production.
• Follow HPAPI containment and EHS procedures and perform risk assessments.
• Update batch records and maintain logs with ALCOA data integrity.

Skills

GMP

GDP

Data Integrity

Documentation

Education

B.Sc. in Organic Chemistry

Tools

DCS

BMR

PDR

Job description

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Department

Development Manufacturing and Commercial

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 always
• Hold self and their teams accountable for the achievement of safety goals
• Govern and Review safety metrics from time to time

Job responsibilities-

• Carrying out manufacturing operations in compliance with current Good Manufacturing Practices, Good Documentation Practices, and Data Integrity policy.
• Always ensure readiness of the facility.
• Handling and monitoring the shift activities.
• Monitoring and control of production operations.
• Coordinate the preparation of the master documents required for production, such as SOP, EOP, ECC, BMR, and PDR.
• Follow HPAPI containment procedures and occupational exposure control requirements.
• Comply with EHS policies, permit-to-work systems, and safe operating procedures.
• Participate in risk assessments, emergency response drills, and safety initiatives
• Attend all the safety-related training and data integrity policies.
• To operate, monitor, and maintain HPAPI manufacturing processes in compliance with cGMP, EHS requirements, quality standards, and containment protocols while ensuring safe, efficient, and compliant production operations.
• Checking the equipment's readiness to initiate/execute manufacturing activity and ensure the raw material's cleanliness before bringing it inside the plant.
• Receipt of raw material and packing material, cross-verify with BMR/PDR, and issue slip with an appropriate label.
• Contemporaneous documentation during batch execution, ensuring documents and annexures are filled and maintained as per ALCOA principles of data integrity guidance.
• Ensuring the availability of consumables like filter cloths, sample bottles, labels, and filter cartridges inside the manufacturing facility.
• Carry out batch charging /filtration/workup/drying activities as per the batch manufacturing record, as well as product handling and packaging.
• Operate the DCS as per the batch manufacturing record and update the batch manufacturing record operations by referring to DCS online.
• Update and maintain the equipment logbook/daily checklist.
• If any deviation/variation is noted, inform immediately to the supervisor for fu1iher proceedings.
• Non-conforming reports and corrective actions implementation in coordination with Senior.
• Cross-checking the mother liquor, aqueous layer, spent solvent, spent solid and hand-over for disposal upon concurrence from relevant PRD personnel.
• Sample submission to QC and follow up with analysis report.
• Taking charge of the previous shift after checking the reaction condition with the batch manufacturing record (BMR) and availability of equipment cleanliness checklist (ECC), raw material and solvent for the next operation.
• Attendance of all training sessions assigned by the training coordinator/as per the training calendar within the due date.
• Ensure documents and annexures are filled out and maintained online.
• Effective performance by coordination with senior management.

EDUCATIONAL QUALIFICATION & EXPERIENCE:

B.Sc. in Organic Chemistry with 1 – 2 Experience in Manufacturing Operations

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 about 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.