Sr Manager / AGM - QA - Reputed Veterinary
- Ideal Placement
- 13 to 20 Yrs
- Visakhapatnam
- 6 years ago
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Job Description
Position Name: Sr Manager / AGM - QALocation: 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: 15 - 20 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 agency s 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.
Employement Category:
Employement Type: Full timeIndustry: Cement / Building MaterialRole Category: General / Other SoftwareFunctional Area: Not ApplicableRole/Responsibilies: Sr Manager / AGM - QA - Reputed VeterinaryContact Details:
Company: Ideal PlacementLocation(s): Visakhapatnam+ View Contact
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Company ProfileIdeal Placement and Consultants (P) Ltd.The world leading manufacturer and Company an ISO 9001 and OHSAS 18001 certified production facility.
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