Assistant Manager

7-12 years

Not Disclosed

Remote

10 Feb. 11, 2025

Job Description

Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Position: Assistant Manager - Quality Assurance
Department: Quality Assurance
Location: Unit 1
Experience Required: 7-12 years
Date Posted: 22-11-2023

Job Summary:

The Assistant Manager will ensure that technology transfer, new product introduction, and product scale-up processes meet the required regulatory and internal standards. This role will involve reviewing and enhancing technology transfer processes, performing risk assessments, and monitoring variations in processes during tech transfer. The position also involves overseeing process validation and cleaning validation activities.

Key Responsibilities:

Technology Transfer:
- Ensure that technology transfer activities are conducted in accordance with Standard Operating Procedures (SOPs).
- Enhance and review the existing technology transfer process to improve efficiency and compliance.
New Product Introduction:
- Oversee and ensure that the introduction of new products is performed as per established SOPs.
Product Scale-up:
- Ensure that product scale-up processes meet regulatory expectations and align with the required standards.
Risk Assessments:
- Review and assess product transfer risk assessments to ensure that all potential risks are identified and mitigated appropriately.
Protocol Review:
- Review Manufacturing Facility Requirements (MFR), Tech Transfer Documents (TTD), and Facility Fitment Protocols to ensure adequacy.
Process Variation Trend Analysis:
- Monitor and trend any variations observed in the processes during technology transfer.
Process/Cleaning Validation & CPV:
- Involve in Process Validation, Cleaning Validation, and Continued Process Verification (CPV) activities to ensure compliance with regulatory and internal requirements.

Skills & Qualifications:

Educational Qualification:
- Relevant degree (e.g., B.Sc, M.Sc, or equivalent) in Life Sciences, Biotech, or related fields.
Experience:
- 9-12 years of experience in technology transfer, new product introduction, or related fields, preferably in the biopharmaceutical industry.
Core Skills:
- Technology Transfer: Experience in managing technology transfer processes and ensuring they align with SOPs and regulatory standards.
- New Product Introduction: Knowledge of the processes for introducing new products, ensuring compliance with internal standards.
- Risk Assessment: Ability to conduct and review risk assessments related to product transfers and scale-up activities.
- MSAT (Manufacturing Science and Technology): Understanding of MSAT activities, ensuring process and product consistency.
- Downstream Purification: Experience in downstream purification processes, particularly the purification of proteins and biomolecules.
- Process Validation & CPV: Hands-on experience with process validation, cleaning validation, and CPV activities.

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Assistant Manager

Job Description

Job Summary:

Key Responsibilities:

Skills & Qualifications:

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