Associate manager Manufacturing Operations

JOB DESCRIPTION

Job Title: Operator Liquid Capsules Filling & Band Sealing Machine.

Job Location: Bangalore – Biocon Park

Department: Pharmaceutical Development

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

Role Accountabilities

• Equipment setup, Operation, dismantling and cleaning of Solution preparation vessels and CIP.
• Responsible for operation and cleaning of Automatic Liquid filling in hard gelatine capsules and Band sealing machine.
• Co-ordination with supervisor or scientist while manufacturing batches, performance qualification of equipment for existing and new equipment.
• Daily logbook entries, verification of instrument as applicable.
• Daily, weekly and monthly balance verification and calibration.
• Identify and implement the manufacturing procedures with compliance to current GMP requirements and shop-floor area walkthrough on weekly basis.
• Entries in batch records, protocols, relevant equipment usage log books.
• Co-ordination with cross functional department for completion of production targets and support for achieving production numbers for weekly, monthly and annually
• Linen management - cleaning, storage and inventory of garments as per SOP.
• Perform identification, assessment and categorization of consumables
• Consumables inventory management, procurement, receipt and verification of consumables during receipt.
• Co-ordination with engineering and maintenance team during preventive maintenance of equipment.
• Daily monitoring of environment monitoring system.
• Equipment, Instrument and area cleaning record and checklist update.
• Complete online and offline training on time.
• Supporting for department for audit preparation and monitoring.
• Support in implementation of cGMP requirements to meet compliance w.r.t. USFDA, EU, MHRA standards.
• Support in preparation of various client visits, regulatory and QP audits.
• Overall adherence to safe practices and procedures of oneself are aligned.
• Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company’s integrity and quality standards.
• Ensuring corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times.
• Ensuring safety of self and lab/plant by adhering to safety protocols and hold self-accountable for the achievement of safety goals.
• Responsible for completing all assigned mandatory trainings related to data integrity, health, and safety measures on time.
• Responsible for ensuring plant activities are in compliance with laid down system procedure and in accordance with regulator’s expectations.
• Responsible to achieve weekly, monthly targets for smooth functioning of production activities, clinical batches manufacturing/commercial batches manufacturing.

Leadership Capabilities

Syngene Values

All employees will consistently demonstrate alignment with our core values

•  Excellence
•  Integrity
•  Professionalism

Specific requirements for this role

1. Experience

1. 1. Relevant hands on experience in Liquid capsules filling in hard gelatine capsules and Band sealing machine.
   2. Manufacturing with strong exposure to handling of solution preparation Vessel and Cleaning in place (CIP).

2. Demonstrated Capability

1. 1. Strong hands on experience in Liquid capsules filling in hard gelatine capsules and Band sealing machine,
   2. In depth knowledge of cGMP, GDP, data integrity, and QMS compliance, with experience in preparation, execution, and review of SOPs, protocols, QRM, and study/validation reports.
   3. Expertise in operation, cleaning, and qualification of critical solution preparation vessels and CIP.
   4. Audit preparedness, and regulatory/customer inspection support, including audit trail review, alarm trending, and inspection floor readiness.

3. Education: ITI Mechanical, ITI Electrical

Experience: 4+ Years of Experience

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.