Job Description
Roles and Responsibilities
Responsible for overall quality control and compliance of cGMP for 2 manufacturing facilities ( 1 - Biosimilar / CDMO Mfg., 1 - Viral Vaccine Mfg. site ) & 1 - R&D center - all based in Bangalore.
Proficient in site remediation to address the regulatory agencies expectations.
Expertise in technology transfers and to oversee the CMO activities as per the Project time lines.
Expertise in due diligence from lab to commercialisation.
- Site remediation to address the regulatory agencies expectations
Experience in managing site quality Audits and responses to the regulatory agencies and Qualified person (QP).
-Implementation of Company Quality policy, Corporate Quality Audit Program & Regulatory Compliance at site
o Supervising, planning & directing the Quality Control laboratories to ensure lab testing provide the highest quality analytical support for manufacturing while ensuring compliance with protocols, cGMP and safety regulations
o Spearheading the work activities of the In process/ ARM / raw material / In vivo testing and microbiology work groups to ensure that testing is executed in a timely and compliant manner
Experience in aseptic manufacturing and control processes.
Experience in cGMP design (lay out), commissioning, validations of green field projects including refurbishment of existing facilities (brown field).
Commissioning and validation of filling lines (Vials/PFS).
Development of URS for various manufacturing and quality equipment.
Basic knowledge of Purified water, water for injection, clean steam generation, heat, and ventilation air conditioning (HVAC) systems.
Experienced Professional in CMC, Stability evaluation, Dossier submission and other regulatory expectations for PQ of vaccines.
Experience of handling large teams with multilocation activities.
Risk assessment around various vaccine projects as per ICH guidelines
Experience in Preclinical Toxicology studies as per WHO expectations
o Ensuring cell banks testing and stability studies of all that products manufactured across the site are executed as per the established protocols
o Ascertaining that validated and approved test methods is followed in the QC laboratories for testing of products manufactured in the site.
o Assessing & approving protocols and reports such as method validation, method transfer, process validation and stability
o Ensuring & supporting the investigations of the market complaints, deviations and Incidences to find out the root cause and review corrective and preventive action plan o Review of data trends and APQR
o Leading, managing, evaluating and imparting training to Quality Control Team to work efficiently under cGMP and QMS
Qualification : Post graduation
Experience : 15 - 25 years
Mandatory : Should have relevant experience in heading QC function for Biosimilar / Viral Vaccine Manufacturing company.
Job Classification
Industry: Pharma, Biotech, Clinical Research
Functional Area: Production, Manufacturing, Maintenance,
Role Category: Senior Management
Role: Senior Management
Employement Type: Full time
Education
Under Graduation: B.Pharma in Pharmacy, B.Sc in Bio-Chemistry, Biology, Microbiology, Chemistry
Post Graduation: M.Pharma in Pharmacy, MS/M.Sc(Science) in Botany, Bio-Chemistry, Biotechnology, Biology, Microbiology, Organic Chemistry
Doctorate: Any Doctorate in Any Specialization
Contact Details:
Company: Strides Arcolab
Location(s): Bengaluru
Website: https:// www.stelis.com
Keyskills:
clean steam generation
filling lines
viral vaccine
Vials/PFS
commissioning validation
Preclinical Toxicology
commissioning
remediation
Dossier submission
HVAC
quality equipment.
stability evaluation
Quality Control
biosimilar
Purified water