Hiring Head For Quality Department For Saykha API Pharma Co (Bharuch)

Hiring For Head of Quality Control/Quality Assurance in API Pharma Compant at Saykha Location

Key Responsibilities

• QA/QC & QMS Leadership
• Regulatory, Customer & Third-Party Audits
• Deviations, OOS/OOT, CAPA & Change Control
• Validation & Quality Risk Management
• Data Integrity / ALCOA+
• DMF / CEP & Regulatory Submissions
• Regulatory Licensing & Inspection Readiness
• QA/QC Team Management
• API / Pharmaceutical Manufacturing Experience
• GMP & ICH Q7

Position: Head Quality Assurance, Quality Control & Regulatory

Location: Saykha, Gujarat

Reporting to: Chief Executive Officer (CEO)

Role Coverage: Saykha & Roha Manufacturing Plants

Head Office Visits: 23 times per month, or as required

Function: Quality Assurance, Quality Control & Regulatory Affairs

Level: Head of Function / HOD

CTC : 30 - 33 LPA

EDUCATIONAL QUALIFICATION

• M.Sc. / M.Pharm / B.Pharm / equivalent qualification in Chemistry, Pharmacy, Pharmaceutical Sciences or a relevant technical discipline.
• Additional qualification or training in Quality Assurance, Regulatory Affairs, GMP or related

areas will be an advantage.

EXPERIENCE

• 1520+ years of relevant experience in QA/QC/Regulatory Affairs within the API / pharmaceutical / regulated manufacturing industry.
• Robust experience in GMP, ICH Q7 and Quality Management Systems.
• Proven experience in leading regulatory, customer and third-party audits/inspections.
• Experience in managing QA and QC teams at manufacturing sites.
• Strong experience in deviations, OOS/OOT, CAPA, change control, validation, data integrity and

Quality Risk Management.

• Experience with DMF/CEP and other regulatory submissions.
• Experience in dealing with international customers and regulatory authorities.
• Experience of managing Quality across multiple manufacturing sites will be strongly preferred.
• Experience in obtaining/maintaining regulatory licences and preparing manufacturing sites for

regulated markets will be an advantage.

Interested candidates can share their updated CV.

Send CV: sdpbhrsolution@gmail.com

Subject: HOD Quality Saykha

SDP HR SOLUTION

Sejal Patel