Job Title

Job description Role & responsibilities 1 Responsible for follow the Heath, Safety and environment norm as per company policy and procedures. 2 Ensure quality standards for all products and manufacturing activities. 3 To organize, educate for and execute activity as per the norms of Quality Assurance objective. 4 Responsible for authorization of site master file. 5 Responsible for authorization of Quality Manual. 6 Responsible for authorization of validation master plan. 7 Approving changes that potentially impact intermediate or API quality and responsible for final authorization of change control. 8 Making sure that critical deviations are investigated and resolved and responsible for final authorization of deviation. 9 Responsible for authorization of process validation protocol and report. 10 Responsible for executing cleaning validation as per protocol and authorizing cleaning validation protocol and report. 11 Approving qualification protocol and report. 12 To review Out of specification / Out of trend cases. 13 To handle the product recall system. 14 To review annual product review of the entire product. 15 To handle the product recall system. 16 To review annual product review of the entire product. 17 To investigate and resolve customers complaints. 18 Coordinate customer and regulatory audits. 19 Provide compliance to customer complaints by coordination with marketing department. 20 Compliance report of various audits by outside agencies and customer. 21 Training to Personnel. 22 Releasing or rejecting APIs and Intermediates. Releasing or rejecting intermediates for use outside the control of manufacturing company. 23 Establishing the system to release or reject raw material, intermediate, packing and labeling materials. 24 Approval of completed batch production record and laboratory control records. 25 Approving specification and standard operating procedure. 26 Making sure that the internal audit is performed as per SOP 27 Review and approve validation protocols and reports in consultation with user department. 28 Making sure that effective system is used for maintaining and calibrating critical equipment. 29 Vendor audit. 30 Implementation of stability studies program of finished products and intermediate to support retest or expiry dates and storage condition. 31 To ensure all equipment require for Quality Control testing are calibrated and maintained in good condition as per SOP. 32 Establishing the system to execute analytical method validation as per the protocol. 33 Ensure that the work force is highly motivated and aligned to the Company objectives. 34 Ensure that adequate quality manpower in line with the demands of the department. 35 Ensure clear role clarity for everyone in the department. 36 Ensure training and development of people ensuring career growth. 37 Co-ordinate with HR for recruitment and training. 38 Performance management through setting goals and timely evaluation. Preferred candidate profile Full time M.SC postgraduate candidates preferred Role: QA / QC Manager Industry Type: Pharmaceutical & Life Sciences Department: Quality Assurance Employment Type: Full Time, Permanent Role Category: Production & Manufacturing Education PG: MS/M.Sc(Science) in Chemistry Key Skills Skills highlighted with are preferred keyskills API Quality Assurance