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Associate Manager documentation

Associate Manager documentation

Syngene

10 - 15 years

35 - 40 Lacs

bengaluru

Posted:None| Platform:

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Skills Required

cell culture ehs data analysis assurance nutrition data management pharma pharmacy packaging gmp

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role-specific:

Preparation, revision and review of Batch Manufacturing Records (BMR), Packing and Dispatch Record (PDR).
Issue, Checking and Review of Operations documents.
Preparation and review of Batch Manufacturing Records, SOPs, PDRs & Protocols.

Conduct training for all DSP employees for prepared BMRs, PDRs and related documents.

Review of TTD s, protocol and Quality Department Protocols related to Operations.
Investigation of Batch failures in Operations.
Monitor and follow good aseptic behavior inside BMP5 DSP Facility.
Support in hiring process and bringing quality workforce to develop a team that is highly respected and engaged towards departmental goals.
Update the batch progress in PRM s and participate in client discussions.
Develop and implement operating methods and procedures designed to eliminate operating problems and improve manufacturing efficiency.

Oversee technology transfer to support scale-up and GMP manufacturing. Build strong relationships with CMOs, to optimize efficiency, productivity, quality and supply assurance.
Design and execute risk-based process characterization studies to define critical process parameters (CPPs) and critical quality attributes (CQAs).
Liaise with regulatory affairs to ensure compliance with industry standards and guidelines.
Ensure that all DSP processes are compliant with cGMP, ICH, FDA, EMEA regulatory requirements.
Develop and implement strategic plans to achieve project milestones and goals.
Mentor and develop team members to foster a high-performance culture.

Education

Master s degree/ bachelor s degree in pharmacy, master s degree in Pharmaceutical Sciences.

Industry Experience

Minimum 10 -15 years of relevant practical experience in mAbs Downstream process and documentation.

Other competencies required for the role

Excellent problem-solving skills and ability to work in a fast-paced, collaborative environment.
Experience with automation and data analysis tools applied for cell culture bioprocessing.
Familiarity with regulatory submissions and quality systems in the biopharmaceutical industry.
Strong interpersonal skills with ability to work with internal and external stakeholders.
Excellent written and verbal communication skills for regulatory documentation and presentations.
Strong knowledge of bioprocessing principles, cell culture techniques, and scale-up methodologies.
Perform review of protocols (study protocols, equipment qualification protocols etc. ). Review the executed protocols and provide adequate support for timely closure of the same
Preparation of general DSP related procedures, protocols, risk assessment and BMRs.
On-time initiation & closure of deviations, investigations, CAPA and change controls.

Safety

and DI Responsibilities:

Adhere to organizational policies & procedures on EHSS, POSH, Data Integrity and IT security.
Always wear the applicable PPEs and adhere to any other Environment, Health, and Safety (EHS) requirements in the workplace for individuals & lab/plant safety.
Understand all necessary safety protocols and always follow the same to ensure safety for all.
Proactively identify near-misses & potential incidents and communicate to supervisor and/or line manager or through the respective web portals.

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