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CIEL/SEL/24121: Manager / Sr Manager in Quality Control in API Pharma - Gummadidala Hyderabad
Hyderabad . Telangana . India
Posted 771 days ago
Job Summary

Job Role:  


· Shall be responsible to ensure the quality control system is in place GLP.

· Shall be responsible for Planning and allotting of day-to-day analysis works.

· Shall be responsible for all instruments implementation of 21 CFR compliance (Audit trail management).

· Shall be responsible for laboratory investigation of Out of Specification, Out of trend and laboratory incidents and related CAPA implementations and effectiveness verification.                                            

· Shall be responsible for Implementation of pharmacopeia updates to products and laboratory systems.

· Shall be responsible for Planning and implementation of Analytical method validations & method transfers and coordination with AR&D for resolving of problems.

· Shall be responsible for Monitoring of calibration management, standard management and verification of pharmacopoeia updates.

· Shall be responsible for Monitoring of stability management and implementation of stability fulfilment to various region customers.

· Shall be responsible for Assess training needs and coordinate for fulfilment of training to all QC personnel on Instrument handling, calibrations, audit trail management and current GMP requirements. Monitor and evaluate the outcome of training and plan for retraining as necessary.

· Shall be responsible for the Approval and rejection of Raw materials, packing materials intermediates and finished products, etc.

· Shall be responsible to ensure review and implementation for each analysis raw data system and review of all instrument qualifications as per cGMP requirements.

· Shall be responsible to attend the customer calls & coordinate with external service engineers for instrument breakdowns.

· Shall be responsible to ensure that all control samples as per product storage conditions and meet the marketing simulate pack.

· Shall be responsible for analytical deficiency compliance Regulatory filings.

· Shall be responsible for review and implementation of department SOP’s and Specification and Method of analysis.

· Shall be responsible for monitoring and follow up of quality control instruments electronic data backup and retrieval.

· Shall be responsible for all microbiology activities.

· Shall be responsible for Audit responses to various customer audit findings.

· Shall report to Head Quality.


21 CFR Compliance, quality control, regulatory, calibration management, standard management, regulatory filing
Recruiter Info
Keerthana RS
About Us
CIEL HR Services

CIEL recruits talent for 2300+ companies in permanent as well as contractual roles spread across industry sectors from its 59 offices in 42 cities in India. We have multiple teams, each specialising in recruitment of talent across a wide range of skills and levels in sectors like Manufacturing, Energy, Infrastructure, IT & Outsourcing, Pharma, Financial Services, Consumer Products and Services. CIEL was listed among the Largest Staffing Companies in India No.1 in terms of Geo spread and at 14th place by revenue as per the report published in Feb 2021 by Staffing Industry Analyst (SIA).

We leverage technology to deliver a superior experience to the candidates who apply for a position open with one of our clients. Our team chooses a handful of best-matching candidates from the pool of available talent in the market based on the candidate's profile, skills and experience. These days, we recruit about 25000+ candidates a year and are growing this number every year.

We believe in finding talent from diverse backgrounds, striking a balance between the aspirations of our candidates with the requirements and thoughts of our clients while recruiting for them. CIEL won the Great Place to Work-Certification for the 2nd time in a row. Our team has remained passionate and committed to the core values of the company: Growth, Professionalism, Dignity and Diversity. CIEL is an ISO 9001:2015 certified company and committed to stakeholder satisfaction through continual improvements in its quality management system.

#GetTheBestOutofUs is its spirit.
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