Manager / Sr Manager - QA - Reputed Veterinary @ Ideal Placement

Job Description

Position Name: Manager / Sr Manager - QA
Location: Visakhapatnam Company: Animal health company specializing in manufacturing of Active Pharmaceutical Ingredients (API) and Finished Dosage Formulations (FDF)
Qualification: M.Sc (Chemistry) /B. Tech - Chemical
Experience: 8- 12 years in Pharmaceutical Industrial Experience of APIs / Drug Manufacturing Units operates for regulatory region.

• Management of site QA Team and regulatory site independently as a first line QA Lead
• Ensuring manufacturing facility and lab operations per CGMP standard 24x7 to meet global standard as per regulatory agencys USFDA, EU, ICH region etc.
• Ensuring management of inspections- Regulatory, customer audits, third party effectively.
• Ensuring effective investigations on deviations, OOS, OOT, Customer Complaints, recalls and Change controls
• Ensuring approval of SOPs, spec, BMR, MOA, and other QMS documents to make sure effective management of QS
• Prior Review and approval on SMF, VMP, Protocols, Reports, and other QMS / Regulatory documents
• Effective technical writings skills on all technical documents such as on SOPs, investigations, PQR, CPV report etc.
• Technical report response writing to remediate the audit observations with effective CAPA strategy and assess the impact at multiple locations
• Review the effectiveness check of CAPA resulted from OOS, Deviation, Customer complaints, recall, audits etc.
• Trending and assessment to work towards process and quality excellence initiatives to implement best practices
• Simplification, standardization, harmonization of standards, systems to implement consistent practices across
• Conducting internal audits at and making sure site operates in state of control and readiness state
• Imparting scheduled and consequential technical training to teams of officer, executives and other staff member.

Required Candidate profile

Required skills, knowledge and characteristics:

• Sound Technical writing and drafting skills
• Team player to work with multiple locations & teams
• Self-motivator & result oriented
• Effective Communication and coordination skills
• Good coordination skills in managing CFTs
• Ability to take technical sound decision independently.

Forward your resume to id***4@id*************s.com.,

Employement Category:

Employement Type: Full time
Industry: Cement / Building Material
Role Category: General / Other Software
Functional Area: Not Applicable
Role/Responsibilies: Manager / Sr Manager - QA - Reputed Veterinary

Contact Details:

Company: Ideal Placement
Location(s): Visakhapatnam

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