Deputy Manager - Validation
Location: Indore, Madhya Pradesh, India
Type: Full-time
Job Description:
We are seeking an experienced and detail-oriented Deputy Manager - Validation to join our team in Indore. The role involves managing qualification and validation activities, including Computer System Validation (CSV), while ensuring compliance with regulatory standards and guidelines.
Key Responsibilities:
Validation & Qualification Execution:
Perform qualification/validation activities, including CSV with the site team and vendors.
Prepare and review protocols and reports for Computer System Validation, infrastructure, network qualification, and serialization/aggregation application qualification.
Execute validation/qualification activities as per the Validation Master Plan (VMP).
Documentation & Compliance:
Review computerized system-related documents.
Maintain documents as per site procedures, including archival and disposition.
Handle QMS activities, including Change Control, SOPs, FRMs, and document management.
Perform IT supplier assessments and audit trail reviews.
Audit & Training:
Handle internal and external audits, ensuring compliance and corrective actions for audit findings.
Provide training to team members, concerned personnel, and new employees on SOPs, on-the-job training, cGMP, 21 CFR, and other regulatory requirements.
Support the site DICO (Data Integrity Compliance Officer) in implementing actions related to Data Integrity awareness.
Coordination & Team Support:
Coordinate with different departments for validation/qualification activities.
Manage onboarding, training, and offboarding of service staff provided by vendor/supplier organizations.
EHS Compliance:
Ensure timely completion of Environment, Health, and Safety (EHS) activities.
Report near misses and incidents as per EHS requirements.
Other Responsibilities:
Execute any additional tasks assigned by superiors.
Attend and provide training sessions (onsite/offsite) to concerned personnel.
Qualifications:
Education:
Bachelor of Pharmacy / Master of Pharmacy / Master of Science / Bachelor of Engineering with a technical background preferred.
Experience:
Proven experience in validation/qualification activities with strong knowledge of cGMP, 21 CFR, and regulatory guidelines.
Strong understanding of QMS and audit processes.
Ability to manage multiple tasks and coordinate with cross-functional teams.
About Us:
Piramal Group has pursued a strategy of organic and inorganic growth for over three decades, driven by core values and a commitment to inclusive growth with ethical practices.
Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering comprehensive development and manufacturing solutions across the drug life cycle. We operate through a globally integrated network, providing services such as drug discovery, pharmaceutical development, clinical trial supplies, commercial supply of APIs, and finished dosage forms. Our expertise spans highly potent APIs, sterile fill/finish, peptide products, and biologics, making us the partner of choice for innovators and generic companies worldwide.
Equal Employment Opportunity:
Piramal Group is an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based on race, ethnicity, religion, gender, sexual orientation, age, disability, or other legally protected characteristics. Employment decisions are based on merit, considering qualifications, skills, performance, and achievements.
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