Manager - Contract Manufacturing

Evoke HR Solutions Pvt. Ltd
  • Mumbai
  • 10-15 lakh
  • 8-13 years
  • 12 Aug 2015

  • Quality Control - Product/ Process

  • Pharmaceuticals/ Life Sciences/ Clinical Research
Job Description

POSITION:: Manager-Contract Manufacturing LOCATION:: Tarapur EDUCATION:: B.Pharm/ M.Pharm/ EXPERIENCE: 8+ SKILLS: Carryout Loan License (LL) &Third Party (TP) vendor audits for Solid Dosage Forms (Tablets, Soft & Hard Gelatin Capsules), Liquid Dosage Forms (Oral suspensions, Syrups and Oral drops), Topical Dosage Forms (Ointments, Creams, Gels and Peptide lotions), Parental dosage form (lyophilized Injections), APIs, Excipients and packaging materials. Audit reports preparation, compliance report review and CAPA closure. Initiation and review of Quality Agreements for loan license (LL) & third party (TP) vendors. Review and approval of Process Validation Protocols & Reports, Stability protocols & Reports Review and approval of master documents like BMR, BPR, STP, Spec etc. Review & approval of Self Assessment check list along with all necessary enclosures Issuance of Manufacturing Clearance certificates to exteal manufacturing partners. Site visits for monitoring of product during pre-validation, validation batches execution at loan license sites. First pack evaluation and manufacturing clearance for new products. Process and analytical verification for Loan License Products. Review & approval of Certificate of Analysis (CoA) and Batch Release Certificates (BRCs) Review & approval of Annual Product Reviews. Handling of market complaints and product failure investigations. Conducting Transport Validation Study for new products Perform Inteal Quality Audits of all Dr.Reddys manufacturing facilities as per the approved schedules. Support to Regulatory inspections at Loan License sites. Pre-text matter approval for art work preparation, review & approval of new products artworks and documents Interact with cross function team members to support in prompt issues resolution

Competencies/Skill sets for this job

Manufacturing License Audit Dosage Capa Audits New Products Vendor Vendors

Job Posted By

About Organisation

Evoke HR Solutions Pvt. Ltd